Powered drivers, intraosseous devices and methods to access bone marrow

ABSTRACT

An apparatus for penetrating bone and accessing bone marrow is provided. The apparatus may include a penetrator assembly and a powered drill to penetrate the bone into the bone marrow. The penetrator assembly may include a trocar having a stylet. The penetrator assembly may also include an outer penetrator having a hollow cannula and a luer lock attachment. The powered drill may include a housing enclosing a motor and a power supply and associated circuitry. The powered drill may also include a connector receptacle for receiving a penetrator assembly connector of the penetrator assembly. The connector receptacle may releasably lock the penetrator assembly connector into place with the powered drill. The power supply may include a rechargeable battery within the housing for supplying power to the motor. A battery indicator may be provided to indicate a level of the battery.

CROSS-REFERENCE IO RELATED APPLICATIONS

The present application is a continuation of pending U.S. patentapplication Ser. No. 17/029,341, entitled “Powered Drivers, IntraosseousDevices And Methods To Access Bone Marrow,” filed Sep. 23, 2020, nowpublished as U.S. Patent Application Publication No. 2021/0052286, whichis a continuation-in-part of pending U.S. patent application Ser. No.16/725,939, entitled “Powered Drivers, Intraosseous Devices And MethodsTo Access Bone Marrow,” filed Dec. 23, 2019, now published as U.S.Patent Application Publication No. 2020/0129186, which is a continuationof U.S. patent application Ser. No. 15/272,647, entitled “PoweredDrivers, Intraosseous Devices And Methods To Access Bone Marrow,” filedSep. 22, 2016, now U.S. Pat. No. 10,512,474, which is continuation ofU.S. patent application Ser. No. 12/061,944, entitled “Powered Drivers,Intraosseous Devices and Methods to Access Bone Marrow,” filed on Apr.3, 2008, now U.S. Pat. No. 9,451,968, which claims priority to U.S.Provisional Patent Application No. 60/910,122, entitled “PoweredDrivers, Intraosseous Device and Methods to Access Bone Marrow,” filedApr. 4, 2007; and U.S. patent application Ser. No. 12/061,944 is acontinuation-in-part of U.S. patent application Ser. No. 11/253,959,entitled “Method and Apparatus to Access Bone Marrow,” filed Oct. 19,2005, now U.S. Pat. No. 8,506,568, and is a continuation-in-part of U.S.patent application Ser. No. 11/253,467, entitled “Apparatus and Methodto Access Bone Marrow,” filed Oct. 19, 2005, now U.S. Pat. No.8,876,826, and is a continuation-in-part of U.S. patent application Ser.No. 10/449,476, entitled “Apparatus and Method to Access Bone Marrow,”filed May 30, 2003, now U.S. Pat. No. 7,699,850, which claims priorityto U.S. Provisional Patent Application No. 60/384,756, entitled“Apparatus and Method to Provide Access to Bone Marrow,” filed May 31,2002.

U.S. patent application Ser. No. 17/029,341 is also acontinuation-in-part of pending U.S. patent application Ser. No.15/854,406, entitled “Vascular Access Kits and Methods,” filed Dec. 26,2017, now U.S. Pat. No. 10,806,491, which is a divisional application ofU.S. patent application Ser. No. 14/791,654, entitled “Vascular AccessKits and Methods,” filed Jul. 6, 2015, now U.S. Pat. No. 9,872,703,which is a continuation of U.S. patent application Ser. No. 11/380,340,entitled “Vascular Access Kits and Methods,” filed Apr. 26, 2006, nowU.S. Pat. No. 9,072,543, which claims the benefit of U.S. ProvisionalPatent Application No. 60/675,246, entitled “Vascular Access Kit,” filedApr. 27, 2005, and which is a continuation-in-part application of U.S.application Ser. No. 10/449,503, entitled “Apparatus And Method ToProvide Emergency Access To Bone Marrow,” filed May 30, 2003, now U.S.Pat. No. 7,670,328, which claims the benefit of U.S. Provisional PatentApplication No. 60/384,756, entitled “Apparatus and Method to ProvideAccess to Bone Marrow,” filed May 31, 2002.

The entire contents of each of the above-referenced applications areincorporated herein by reference in their entirety.

TECHNICAL FIELD

The present disclosure is related in general to medical devices operableto access bone marrow, and more specifically to an apparatus and methodfor penetrating a bone and associated bone marrow with a powered driver,inserting an intraosseous device into the bone and associated bonemarrow, and providing access to the bone, bone marrow, and otherportions of a patient's vascular system.

BACKGROUND

Every year, millions of patients are treated for life-threateningemergencies in the United States. Such emergencies include shock,trauma, cardiac arrest, drug overdoses, diabetic ketoacidosis,arrhythmias, burns, and status epilepticus just to name a few. Forexample, according to the American Heart Association, more than1,500,000 patients suffer from heart attacks (myocardial infarctions)every year, with over 500,000 of them dying from its devastatingcomplications.

Obtaining satisfactorily vascular access may be a critical problem inapproximately five (5%) percent to ten (10%) percent of patients treatedin either prehospital or hospital settings. In the U.S. approximatelysix million patients annually may experience problems with traditionalintravenous (IV) access. An essential element for treating all suchemergencies is the rapid establishment of an intravenous line in orderto administer drugs and fluids directly into the circulatory system.Whether in the ambulance by paramedics, or in the emergency room byemergency specialists, the goal is the same—to start an IV in order toadminister life-saving drugs and fluids. To a large degree, the abilityto successfully treat such critical emergencies is dependent on theskill and luck of the operator in accomplishing vascular access.

While it is relatively easy to start an IV on some patients, doctors,nurses and paramedics often experience great difficulty establishing IVaccess in approximately twenty (20%) percent of patients. These patientsare probed repeatedly with sharp needles in an attempt to solve thisproblem and may require an invasive procedure to finally establish anintravenous route. A further complicating factor in achieving IV accessoccurs “in the field” e.g. at the scene of an accident or duringambulance transport where it is difficult to see the target andexcessive motion make accessing the venous system very difficult. Thesuccess rate on the battlefield is often much lower where Army medicsmay only be about twenty-nine (29%) percent successful in starting an IVline during emergency conditions in the field. These patients are probedrepeatedly with sharp needles in an attempt to solve this problem andmay require an invasive procedure to finally establish an intravenousroute.

In the case of some patients (e.g., those with chronic disease or theelderly), the availability of easily-accessible veins may be depleted.Other patients may have no available IV sites due to anatomical scarcityof peripheral veins, obesity, extreme dehydration, and/or previous IVdrug use. For these patients, finding a suitable site for administeringlifesaving drugs becomes a monumental and frustrating task. Whilemorbidity and mortality statistics are not generally available, it isknown that many patients with life-threatening emergencies have died ofensuing complications because access to the vascular system withlife-saving IV therapy was delayed or simply not possible. For suchpatients, an alternative approach is required.

An accepted alternative route to give IV medications and fluids isthrough bone marrow by providing intraosseous (IO) access. Drugs andother fluids may enter a patient's vascular system just as rapidly viathe intraosseous route as when given intravenously. Bone and associatedbone marrow may be considered a large non-collapsible vein. Theintraosseous route has been used for alternative emergency access inpediatric patients, whose bones are soft enough to permit manualinsertion of intraosseous needles.

Powered drivers associated with intraosseous devices typically include ahousing with various types of motors and/or gear assemblies disposedtherein. A rotatable shaft may be disposed within the housing andconnected with a gear assembly. Various types of fittings, connections,connectors and/or connector receptacles may be provided at one end ofthe rotatable shaft extending from the housing to releasably engage anintraosseous device with the powered driver.

Vascular system access may be essential for treatment of many seriousdiseases, chronic conditions and acute emergency situations. Yet, manypatients experience extreme difficulty obtaining effective treatmentbecause of inability to obtain or maintain IV access. An intraosseousspace provides a direct conduit to a patent's vascular system andsystemic circulation. Therefore, intraosseous access is generally aneffective route to administer a wide variety of drugs, other medicationsand fluids equivalent to IV access. Rapid intraosseous access offersgreat promise for almost any serious emergency that requires vascularaccess to administer life saving drugs, other medications and/or fluidswhen traditional IV access is difficult or impossible.

Bone marrow typically includes blood, blood forming cells, andconnective tissue disposed in an intraosseous space or cavity surroundedby compact bone. Long bones such as the tibia typically have anelongated central cavity filled with yellow bone marrow and adipose orconnective tissue. Such cavities may also be referred to as a “medullarycavity,” “bone marrow cavity” and/or “intraosseous space.”

Compact bone disposed nearer the anterior or dorsal surface shall bereferred to as “anterior compact bone” or “anterior bone cortex.”Compact bone disposed farther from the dorsal or anterior surface may bereferred to as “posterior compact bone” or “posterior bone cortex.”

The upper tibia proximate a patient's knee or the humeral head proximatea patient's shoulder may be used as insertion sites for an intraosseousdevice to establish access with the patient's vascular system. Sternalaccess may also be used as an insertion site. Availability of multipleintraosseous insertion sites and associated target areas in adjacentbone marrow have proven to be especially important in applications suchas emergency treatment of battlefield casualties or other mass casualtysituations. Teachings of the present disclosure may be used at a widevariety of insertion sites and target areas. Teachings of the presentdisclosure are not limited to power drivers and/or intraosseous deviceswhich may be inserted at the proximal tibia, distal tibia, humerus, orsternum.

Intraosseous access may be used as a “bridge” for temporary fluid and/ordrug therapy during emergency conditions until conventional IV sites canbe found and used. Conventional IV sites often become available becausefluids and/or medication provided via intraosseous access may stabilizea patient and expand veins and other portions of a patient's vascularsystem. Intraosseous devices and associated procedures incorporatingteachings of the present disclosure may become standard care foradministering medications and fluids in situations when IV access isdifficult or not possible.

Intraosseous access may be used as a “routine” procedure with chronicconditions which substantially reduce or eliminate availability ofconventional IV sites. Examples of such chronic conditions may include,but are not limited to, dialysis patients, patients in intensive careunits and epilepsy patients. Intraosseous devices and associatedapparatus incorporating teachings of the present disclosure may bequickly and safely used to provide intraosseous access to a patient'svascular system in difficult cases such as status epilepticus to givemedical personnel an opportunity to administer crucial medicationsand/or fluids. Further examples of such acute and chronic conditions arelisted near the end of this written description.

SUMMARY

In accordance with teachings of the present disclosure, apparatus andmethods are provided for gaining rapid access to a patient's bone marrowand vascular system.

In one embodiment, an apparatus for penetrating a bone marrow isprovided that includes a housing and a penetrator assembly. Thepenetrator assembly is operable to penetrate the bone marrow, having aremovable inner trocar and an outer penetrator. A connector operable toreleasably attach the penetrator assembly to a drill shaft is included.The drill shaft is operable to connect the penetrator assembly to a gearassembly. The gear assembly is operable to engage and rotate the drillshaft. A motor operable to engage the gear assembly and drive thepenetrator into the bone marrow by rotation of the drill shaft and apower supply and associated circuitry operable to power the motor arealso included. The power supply may comprise at least one rechargeablebattery.

In another embodiment, an apparatus for penetrating a bone marrow isprovided that includes a housing and a penetrator assembly, operable topenetrate the bone marrow. A connector operable to releasably attach thepenetrator assembly to a drill shaft, the drill shaft operable toconnect the penetrator assembly to a reduction gear assembly isincluded. A reduction gear assembly operable to engage and rotate thedrill shaft and a motor operable to engage the reduction gear assemblyand drive the penetrator into the bone marrow by rotation of the drillshaft are also included. A power supply and associated circuitryoperable to power the motor are also provided. The power supply maycomprise at least one rechargeable battery.

In one embodiment, a penetrator assembly operable to provide access to abone marrow comprising an outer penetrator and a removable inner trocaroperable to penetrate the bone marrow is provided. A connector operableto releasably attach the penetrator assembly to a power drill is alsoincluded.

In another embodiment, a penetrator assembly operable to provide accessto a bone marrow comprising an outer penetrator and a removable innertrocar operable to penetrate the bone marrow is provided. The innertrocar includes a handle, the handle including a grasping means thatallows a user to grasp and manipulate the device. The outer penetratorincludes a handle, the handle including a grasping means, and alsoincludes a flange operable to engage an insertion site proximate thebone marrow. A connector operable to releasably attach the penetratorassembly to a power drill is also provided. The inner trocar is operableto releasably engage the connector.

In one embodiment, a method of accessing a bone marrow is provided thatincludes inserting a penetrator assembly into the bone marrow by meansof a powered apparatus, detaching the powered apparatus from thepenetrator, removing an inner trocar from an outer penetrator of theassembly and attaching a right angle connector to the outer penetrator.

In another embodiment, a method of accessing a bone marrow is providedthat includes inserting a penetrator assembly into the bone marrow bymeans of a powered apparatus, detaching the powered apparatus from thepenetrator, removing an inner trocar from an outer penetrator of theassembly and attaching an adapter suitable to convey medications orfluids to the bone marrow.

In yet another embodiment, a method of manufacturing an apparatusoperable to penetrate a bone marrow is provided that includesmanufacturing a housing having a connector operable to releasably attacha penetrator assembly to a drill shaft, a drill gear assembly, a gearassembly operable to engage and rotate the drill shaft, a motor operableto engage the gear assembly and drive a penetrator assembly into thebone marrow and a power supply and associated circuitry operable topower the motor and manufacturing a penetrator assembly operable toreleasably attach to the connector. The power supply may comprise atleast one rechargeable battery.

In a further embodiment, a kit for use in penetrating a bone marrow inan extremity is provided that includes a carrying case, an apparatus forpenetrating the bone marrow including a housing and penetratorassemblies operable to penetrate the bone marrow, a removable innertrocar and an outer penetrator forming portions of at least one of thepenetrator assemblies, at least one connector operable to releasablyattach the penetrator assemblies to a drill shaft, a gear assemblyoperable to engage and rotate the drill shaft, a motor operable toengage the reduction gear assembly and drive at least one of thepenetrator assemblies into the bone marrow and a power supply andassociated circuitry to power the motor and a strap operable toimmobilize the outer penetrator to a site in an extremity. The powersupply may comprise at least one rechargeable battery.

One embodiment may include a powered driver operable to insert anintraosseous device into a patient's bone marrow at a selected targetsite. The powered driver may include a variable speed mechanism such asa low voltage potentiometer or any other electrical device satisfactoryto allow varying the speed of an associated motor.

One embodiment of the present disclosure may provide an apparatusoperable to insert an intraosseous device into a bone and associatedbone marrow. The apparatus may include a housing, a drive shaft, amotor, a power supply and associated electrical circuit, and a light.The drive shaft may extend from an opening in the housing and may beoperable to releasably engage the intraosseous device. The motor may bedisposed within the housing and rotatably engaged with the drive shaft.The power supply and associated electrical circuit may be operable topower the motor. The light may extend from the housing and be connectedto the power supply and the light may be operable to illuminate aninsertion site for the intraosseous device.

Another embodiment of the present disclosure may provide a powereddriver operable to insert an intraosseous device into a bone andassociated bone marrow. The powered driver may include a housing, adrive shaft extending from the housing, a motor, a power supply,electrical circuits, and a switch connected to the electrical circuits.The drive shaft may be operable to releasably engage the intraosseousdevice. The motor may be disposed within the housing and rotatablyengaged with the drive shaft. The power supply and associated electricalcircuit may be operable to power the motor. The switch may be operableto activate the motor to rotate the drive shaft.

Another embodiment of the present disclosure may provide an apparatusoperable to insert an intraosseous device into a bone and associatedbone marrow and to assist with other medical procedures. The apparatusmay include a powered driver, a drive shaft, a motor, a power supply andelectrical circuits, a switch, and a suction pump. The powered drivermay have a housing with one end of the drive shaft extending therefrom.The one end of the drive shaft may be operable to releasably engage theintraosseous device. The motor may be disposed within the housing androtatably engaged with the drive shaft. The power supply and electricalcircuits may be operable to power the motor. The switch may be operableto activate the motor to rotate the drill shaft. The suction pump mayhave a connector operable to be releasably engaged with the one end ofthe drive shaft whereby the powered driver may operate the pump.

The present disclosure also relates to kits, apparatus contained in suchkits and associated procedures to obtain access to a patient's vascularsystem. For some embodiments such kits may include intravenous accessdevices and intraosseous access devices. Such kits may be used in bothemergency situations or more routine procedures associated with treatingchronic conditions. The present disclosure may provide apparatus andmethods to establish vascular access during treatment of a patient at awide variety of locations and facilities including, but not limited to,accident sites, emergency rooms, battlefields, emergency medicalservices (EMS) facilities, oncology treatment centers, chromic diseasetreatment facilities and veterinary applications.

Technical benefits of some embodiments may include providing portablekits with devices and components for rapid penetration of bone and bonemarrow to provide access to a patient's vascular system.

Technical benefits of some embodiments may include devices andcomponents for rapid penetration of bone and associated bone marrow.Such devices and components may be placed in a kit for use in accessinga patient's vascular system.

Technical benefits of some embodiments may include obtaining fast,inexpensive access to a patient's vascular system with minimal risk.Apparatus and methods incorporating teachings of the present disclosuremay be used to provide IO and IV access so that drugs and/or fluids canbe injected into associated bone marrow.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete and thorough understanding of the present embodimentsand advantages thereof may be acquired by referring to the followingdescription taken in conjunction with the accompanying drawings, inwhich like reference numbers indicate like features, and wherein:

FIG. 1A is a schematic drawing showing an isometric view of oneembodiment of the present disclosure.

FIG. 1B is a schematic drawing showing an isometric view of oneembodiment of the present disclosure.

FIG. 2A is a schematic drawing showing an isometric view of oneembodiment of the present disclosure.

FIG. 2B is a schematic drawing showing an isometric view of oneembodiment of the present disclosure.

FIGS. 3A-C illustrate a side and cross-sectional view of one embodimentof the present disclosure.

FIGS. 4A-C illustrate various alternate embodiments of a reduction gearmechanism that may be included in an embodiment of the presentdisclosure.

FIGS. 5A-C illustrate one embodiment of a penetrator assembly of thepresent disclosure.

FIGS. 6A-C illustrate various alternate embodiments of a penetratorassembly connector of the present disclosure.

FIG. 7A illustrates one embodiment of a penetrator assembly of thepresent disclosure.

FIG. 7B illustrates a cross-sectional view of one embodiment of apenetrator assembly of the present disclosure.

FIG. 7C illustrates one embodiment of an inner trocar in cross sectionof the present disclosure.

FIG. 7D illustrates one embodiment of an outer penetrator in crosssection of the present disclosure.

FIGS. 7E-G illustrate examples of release mechanisms of the presentdisclosure.

FIG. 8A illustrates one embodiment of a tip of a penetrator assembly ofthe present disclosure.

FIG. 8B illustrates one embodiment of a tip of a penetrator assembly ofthe present disclosure.

FIG. 9 illustrates one embodiment of a kit to access the bone marrow ofthe present disclosure.

FIG. 10 illustrates one embodiment of a connector to attach to an outerpenetrator of the present disclosure.

FIG. 11A is a schematic drawing in section showing one embodiment of arechargeable powered driver incorporating teachings of the presentdisclosure.

FIG. 11B is a schematic drawing showing an isometric view of therechargeable powered driver of FIG. 11A;

FIG. 12A is a schematic drawing showing one example of an electricalpower circuit incorporating teachings of the present disclosure.

FIG. 12B is a schematic drawing showing an example of one component of avariable speed controller satisfactory for use with a powered driver inaccordance with teachings of the present disclosure.

FIG. 12C is an isometric drawing showing an example of another componentof a variable speed controller which may be used with a powered driverin accordance with teachings of the present disclosure.

FIG. 12D is a schematic drawing showing an example of an electricalpower circuit having an enable switch or safety switch incorporatingteachings of the present disclosure.

FIG. 13A is a schematic drawing showing a powered driver disposed in acharging cradle incorporating teachings of the present disclosure.

FIG. 13B is a schematic drawing showing an isometric view of a powereddriver having a battery charge indicator incorporating teachings of thepresent disclosure.

FIG. 13C is a schematic drawing with portions broken away showinganother example of a charge indicator for a powered driver incorporatingteachings of the present disclosure.

FIG. 13D is a schematic drawing with portions broken away showing stillanother example of a power supply status indicator for a powered driverincorporating teachings of the present disclosure.

FIG. 14A is a schematic drawing showing an isometric view of a powereddriver having a light in accordance with teachings of the presentdisclosure.

FIG. 14B is a schematic drawing showing an isometric view of anotherexample of a light disposed on a powered driver in accordance withteachings of the present disclosure.

FIG. 14C is a schematic drawing showing another example of arechargeable powered driver incorporating teachings of the presentdisclosure.

FIG. 15A is a schematic drawing showing an isometric view of a powereddriver having a safety switch incorporating teachings of the presentdisclosure.

FIG. 15B is a schematic drawing showing an isometric view of anotherpowered driver having an enable switch incorporating teachings of thepresent disclosure.

FIG. 15C is a schematic drawing showing an isometric view of stillanother powered driver having a safety switch incorporating teachings ofthe present disclosure.

FIG. 16A is a schematic drawing in section with portions broken awayshowing one example of a protective covering for a trigger assembly orswitch assembly of a powered driver incorporating teachings of thepresent disclosure.

FIG. 16B is a schematic drawing showing another example of a protectivecover for a trigger assembly or switch assembly of a powered driverincorporating teachings of the present disclosure.

FIG. 16C is an isometric drawing showing a cross-section of a powereddriver incorporating teachings of the present disclosure.

FIG. 17A is a schematic drawing showing a wall mounted cradle for apowered driver incorporating teachings of the present disclosure.

FIG. 17B is a schematic drawing showing another isometric view of acradle and powered driver of FIG. 17B.

FIG. 18A is a schematic drawing showing one example of an intraosseousneedle set which may be inserted into a patient's vascular system usinga powered driver.

FIG. 18B is a schematic drawing showing an isometric view with portionsbroken away of a connector receptacle which may be releasably engagedwith a powered driver incorporating teachings of the present disclosure.

FIG. 19A is a schematic drawing showing an isometric view of oneembodiment of a hub which may be installed by a powered driver inaccordance with teachings of the present disclosure.

FIG. 19B is a schematic drawing showing an isometric view of oneembodiment of a connector which may be installed by a powered driver inaccordance with teachings of the present disclosure.

FIG. 20 is a schematic drawing showing an isometric view with portionsbroken away of a pump which may be operated by a powered driver inaccordance with teachings of the present disclosure.

FIG. 21 illustrates a powered driver including a battery indicatoraccording to another aspect of the present disclosure.

FIG. 22 illustrates a powered driver including a rechargeable batteryaccording to another aspect of the present disclosure.

FIG. 23A is a schematic drawing showing an isometric view of one exampleof a kit which may be used to obtain access to a patient's vascularsystem in a first, closed position.

FIG. 23B is a schematic, drawing with portions broken away showing oneexample of a breakable seal which may be used to indicate status of thekit of FIG. 23A.

FIG. 24A is a schematic drawing showing an isometric view of the kit inFIG. 23A in an open position along with examples of intraosseous andintravenous devices and components disposed therein.

FIG. 24B is a schematic drawing showing one side of a divider or panelwhich may be disposed in the kit of FIG. 24A along with examples ofintraosseous and intravenous devices and components attached thereto.

FIG. 25 is a schematic drawing showing an isometric view of one exampleof a securing device which may be installed in a kit to releasably holda drive in accordance with teachings of the present disclosure.

FIG. 26 is a schematic drawing showing one example of a powered driverand penetrator assembly which may be included in a kit in accordancewith teachings of the present disclosure.

FIG. 27 is a schematic drawing showing an isometric view of one exampleof a powered driver and securing device releasably engaged with eachother in accordance with teachings of the present disclosure.

FIG. 28 is a schematic drawing showing an isometric view of one exampleof a kit in a second, open position with a powered driver installed in asecuring device operable to recharge a battery carried within thepowered driver in accordance with teachings of the present disclosure.

FIG. 29A is a schematic drawing showing another example of a kit in afirst, closed position incorporating teachings of the presentdisclosure.

FIG. 29B is a schematic drawing showing an isometric view of the kit ofFIG. 29A in a second, open position.

FIG. 30 is a schematic drawing in section showing an intraosseous deviceinserted into bone marrow of a patient after using various devices andcomponents carried in a kit in accordance with the teachings of thepresent disclosure.

FIG. 31 is a schematic drawing in elevation with portions broken awayshowing one example of a strap and supporting structure which may becarried in a kit and used to position an intraosseous device at aselected insertion site.

FIG. 32 is a schematic drawing showing a plan view with portions brokenaway of another example of a strap and supporting structure which may becarried in a kit and used to position an intraosseous device at aselected insertion site.

FIG. 33 is a schematic drawing in section and in elevation showing anintraosseous device inserted into bone marrow of a patient along withanother example of a strap and supporting structure which may be carriedin a kit in accordance, with teachings of the present disclosure.

FIG. 34 is a schematic drawing in section showing an intraosseous deviceinserted into bone marrow of a patient along with another example of astrap and supporting structure which may be carried in a kit inaccordance with teachings of the present disclosure.

FIG. 35 is a schematic drawing in section showing an intraosseous deviceinserted into bone marrow of a patient along with another example of astrap and supporting structure which may be carried in a kit inaccordance with teachings of the present disclosure.

FIG. 36 is a schematic drawing in section showing another example of astrap and supporting structure which may be satisfactorily used toposition an intraosseous device at a selected insertion site.

FIG. 37 is a schematic drawing in section with portions broken away ofthe strap and supporting structure of FIG. 36.

FIG. 38 is a schematic drawing showing an isometric view with portionsbroken away of the strap and supporting structure of FIGS. 36 and 37releasably attached to the leg of a patient proximate the tibia.

FIG. 39 is a schematic drawing showing another example of a powereddriver which may be carried in a kit incorporating teachings of thepresent disclosure along with a strap and supporting structure for anassociated intraosseous device.

FIG. 40A is a schematic drawing showing an exploded view of a manualdriver and associated intraosseous device which may be carried in a kitin accordance with teachings of the present disclosure.

FIG. 40B is a schematic drawing showing an isometric view of a containerwith one example of an intraosseous device disposed therein.

FIG. 41 is a schematic drawing showing another example of a manualdriver which may be carried in a kit in accordance with teachings of thepresent disclosure.

DETAILED DESCRIPTION

Preferred embodiments of the invention and its advantages are bestunderstood by reference to FIGS. 1A-41 wherein like numbers refer tosame and like parts.

Apparatus and methods incorporating teachings of the present disclosuremay be used to provide intraosseous access to a patient's vascularsystem in the sternum, the proximal humerus (the shoulder area), theproximal tibia (below the knee) and the distal tibia (above the insideof the ankle). The distal tibia may provide easier vascular access tomorbidly obese patients. The distal tibia is usually a thinner area ofthe body. Using the distal tibia as an insertion site may allowemergency medical service personnel to pump medications and fluids intothe body of obese patients when regular conventional IV access isdifficult. EMS personnel may often not be able to start IVs in obesepatients because their size may obscure many of the veins used forconventional IV access. Adipose tissue (fat) around normal IO accesssites may be so thick that EMS personnel can't reach adjacent the bonewith standard IO needles. Therefore, the distal tibia may provide an IOaccess site for the overweight population.

One aspect of the present disclosure may include providing a powereddriver and respective IO needle sets for safe and controlled vascularaccess to provide medication and fluids to bone marrow, to removebiopsies of bone and/or bone marrow and to aspirate bone marrow.

Apparatus and methods incorporating teachings of the present disclosuremay be used with patients of all ages and weights. For example, one IOneedle set may be appropriate for patients within the weight range of 3kilograms to 39 kilograms. A second IO needle set may be satisfactoryfor use with patients weighing 40 kilograms or more.

For still other applications, teeth formed on one end of a cannula orcatheter may be bent radially outward to reduce the amount of time andthe amount of force required to penetrate bone and associated bonemarrow using the cannula or catheter. For some applications a powereddriver and aspiration needle set formed in accordance with teachings ofthe present disclosure may provide access to a patient's bone marrowusing the same amount of torque. The length of time for penetrating arelatively hard bone may be increased as compared with the length oftime required to penetrate a relatively softer bone.

The circuit may limit current supplied to the motor to protectassociated batteries and to protect the motor for high current flow.High current flow may correspond with high torque which indicatesimproper use or operation of the powered driver. High torque may alsoindicate that the powered driver is not driving into bone. Current flowthrough the motor may be directly related to torque produced by thedrive shaft. For some applications the circuit may indicate when currentflow through the motor is typical for penetrating the hard outer layerof a bone (compact bone issue) with an IO device. The circuit may alsoindicate when current flow through the motor decreases in response tothe TO device penetrating associated bone marrow.

For some embodiments the powered driver may include a trigger assemblyoperable to activate a low speed switch, a high speed switch and/or turnan associated motor off.

For some embodiments the powered driver may include a drive shaft havingone end with a generally hexagonal cross section operable to bereleasably engaged with intraosseous devices including, but not limitedto, biopsy needles and bone marrow aspiration needles.

For some embodiments the powered driver may include a gear assemblyrotatably attached to a motor. The gear assembly may have a speedreducing ratio between 60:1 and 80:1. For some applications the gearassembly may reduce speed of rotation of an attached motor at a ratio ofapproximately 66:1 or 77:1.

Apparatus and methods incorporating teachings of the present disclosuremay include using a first IO needle set having a fifteen (15) gagecannula with a length of approximately fifteen (15) millimeters toestablish vascular access for patients weighing between approximatelythree (3) kilograms and thirty nine (39) kilograms. A second TO needleset having a fifteen (15) gage cannula with an approximate length oftwenty-five (25) millimeters may be used to establish vascular accessfor patients weighing forty (40) kilograms and greater.

For some applications intraosseous needles and needle sets incorporatingteachings of the present disclosure may be formed from 304-stainlesssteel. Standard Luer lock catheter connections may be provided on eachIO needle. IO needles and needle sets incorporating teachings of thepresent disclosure may be easily removed from an insertion site withoutthe use of special tooling or equipment. The reduced size and weight ofdrivers and IO devices incorporating teachings of the present disclosureaccommodate use in emergency crash carts and emergency medical vehicles.

The term “driver” as used in this application may include any type ofpowered driver or manual driver satisfactory for inserting anintraosseous (TO) device including, but not limited to, a penetratorassembly, catheter, IO needle, IO needle set, biopsy needle oraspiration needle into a selected portion of a patient's vascularsystem. Various techniques may be satisfactorily used to releasablyengage or attach an IO device and/or penetrator assembly with a driverincorporating teachings of the present disclosure. A wide variety ofconnectors and associated connector receptacles, fittings and/or othertypes of connections with various dimensions and configurations may besatisfactorily used to releasably engage an IO device with a driver. Abattery powered driver incorporating teachings of the present disclosuremay be used to insert an intraosseous device into a selected target areain ten seconds or less.

The term “intraosseous (TO) device” may be used in this application toinclude any hollow needle, hollow drive bit, penetrator assembly, bonepenetrator, catheter, cannula, trocar, inner penetrator, outerpenetrator, IO needle or IO needle set operable to provide access to anintraosseous space or interior portions of a bone.

For some applications an IO needle or IO needle set may include aconnector with a trocar or stylet extending from a first end of theconnector. A second end of the connector may be operable to bereleasably engaged with a powered driver incorporating teachings of thepresent disclosure. An IO needle or IO needle set may also include a hubwith a hollow cannula or catheter extending from a first end of the hub.A second end of the hub may include an opening sized to allow insertingthe trocar through the opening and the hollow cannula. The second end ofthe hub may also be operable to be releasably engaged with the first endof the connector. As previously noted, the second end of the connectormay be releasably engaged with a powered driver. A wide variety ofconnectors and hubs may be used with an IO device incorporating teachingof the present disclosure. The present disclosure is not limited toconnector 1180 or hub 1200 as shown in FIGS. 18A and 18B.

Various features and benefits of the present disclosure may be describedwith respect to a kit having a driver to insert an intraosseous (IO)device into bone marrow of a patient at a selected insertion site.However, a kit with devices and components incorporating teachings ofthe present disclosure may be satisfactorily used to access variousportions of a patient's vascular system. The present disclosure is notlimited to IO devices and procedures.

The term “kit” may be used in this application to describe a widevariety of bags, containers, carrying cases and other portableenclosures which may be used to carry and store intraosseous devicesand/or intravenous devices along with related components andaccessories. Such kits and their contents along with applicableprocedures may be used to provide access to a patient's vascular systemin accordance with teachings of the present disclosure.

Various examples of an apparatus operable to access the bone marrow inaccordance with the present invention are shown generally in FIGS. 1Aand 1B at 10. Apparatus 10 as shown in FIGS. 1A and 1B generallyincludes housing 12 and penetrator assembly 14. Housing 12 includeshandle 16 that is sized and contoured to fit the hand of an operator.Handle 16 may include on/off switch 22 and safety 24. Penetratorassembly 14 includes outer penetrator 18, inner trocar (not expresslyshown) and penetrator assembly connector 20.

FIGS. 2A and 2B illustrate an alternate embodiment of the presentinvention. Apparatus 10 a generally includes housing 12 and penetratorassembly 14 a. Housing 12 includes handle 16 that is sized and contouredto fit the hand of an operator. Handle 16 may include an on/off switch22. Penetrator assembly 14 a includes outer penetrator 18, inner trocar(not expressly shown) and penetrator assembly connector 20. Penetratorassembly 14 a may include penetrator shield 26. An outer penetrator mayinclude either a trocar, a needle, a cannula, a hollow tube, a drill bitor a hollow drill bit.

FIGS. 3A and 3B illustrate yet another embodiment of the presentinvention. Apparatus 10 b generally includes housing 12 and a penetratorassembly (not expressly shown). Housing 12 includes handle 16 and on/offswitch 22. Penetrator assembly may include penetrator (not expresslyshown) and a connector, for example a pentagonal connector 20 as shownin FIG. 3A. As shown in FIG. 3B, housing 12 encloses motor 30, powersupply 32, for example four or more AA batteries, motor connecting wires34 between power supply 32 and motor 30 and switch connecting wires 36between on/off switch 22 and power supply 32. The power supply to theapparatus may be any suitable number of AA batteries or any other typeof battery, a source of direct current, a source of alternating currentor a source of air or gas power. The motor may be reciprocating orrotational. Thruster bearing 45, for example a washer, may be locatedadjacent to housing 12 where drill shaft 40 exits housing 12. Thrusterbearing 45 prevents the thrust or penetration force of drilling frombeing placed on gear assembly 38 as penetrator is drilled into bone.FIG. 3C shows one embodiment of the invention where drill shaft 40 maybe separated into two interdigitating pieces at 42 in order to allow thetwo ends of drill shaft 40 to slide in and out as bone is penetrated toavoid applying excessive force to a gear assembly.

In FIG. 3B gear assembly 38 is coupled to motor 30. Gear assembly 38 maybe a reduction gear assembly such as that shown in FIG. 3B thatfunctions to reduce the revolutions per minute (RPMs) between the motorand drill shaft 40 and to increase drill shaft torque. Depending on thetype of motor employed in the invention, gear assembly may or not be ofthe reduction type.

By way of example and not limitation, a reduction gear assembly, forexample a worm gear assembly is shown in more detail in FIG. 4A and mayinclude first connector 43 that connects shaft 44 of motor 30 to wormgear 46. Worm gear 46 may engage spur gear 47. Reduction gear assembly38 may be used to decrease the RPMs between the motor and penetratorassembly to provide an optimum RPM at the point of insertion ofpenetrator assembly into bone. Reduction gear assembly 38 may also beused to increase the torque of drill shaft and drilling power.

FIG. 4B illustrates one embodiment of reduction gear assembly 38 whereina first spur gear 47 engages a second spur gear 49. FIG. 4C illustratesan alternate embodiment of reduction gear assembly 38 wherein spur gear47 is offset from mitered gear 48 that may be preferable in someembodiments of the present invention. Other gears may be used in areduction gear assembly, for example a planetary gear (not expresslyshown) that may be used alone or in combination with a worm gear or aspur gear. In one embodiment of the current invention, gear assembly maybe any suitable gear arrangement and is not limited to a reduction gearassembly.

FIGS. 5A-5C illustrate one embodiment of a penetrator assembly 55operable to penetrate a bone marrow, having a removable inner trocar 50and an outer penetrator 52. Also shown in FIG. 5A is a penetrator shield26 that may be used to shield penetrator assembly 55 from inadvertentengagement and also serves to preserve needle sterility. In someembodiments outer penetrator 52 may be a type of needle or cannula. FIG.5B illustrates outer penetrator 52 may include a male connecting piece56 operable to engage a complementary female connecting piece 54 ofinner trocar 50. Adjacent to male connecting piece 56 is connectingpiece locking mechanism 58 that locks into position on female connectingpiece 54. Alternatively outer penetrator may include a female connectingpiece suitable to engage a complementary male connecting piece of aninner trocar. Luer lock attachment 57 is coupled to male connectingpiece 56 for connection to an intravenous tubing or syringe after theouter penetrator is positioned in the bone marrow. Male connecting piece56 and female connecting piece 54 may also be of the luer-lock type.Inner trocar 50 includes stylet 53 that keeps outer penetrator 52 fromgetting plugged with debris created during drilling. Stylet 53 acts incombination with cannula portion 51 of outer penetrator. Outerpenetrator 52 may include flange 60 that abuts or interfaces the skin ofan insertion site and may be used to stabilize a penetrator assembly atthe time of insertion. Penetrator assembly 55 may include various typesof connectors, such as connector 62 that may be used to connectpenetrator assembly 55 to a powered drill. Connector 62 may bepentagonal as shown in FIGS. 5A and 5C.

In one embodiment, the invention may include a specialized connectorbetween the penetrator assembly and a powered drill. The connectorperforms at least two functions, a connecting function and a releasingfunction. The connecting function may be performed by various mechanismssuch as a pentagonal male-female fitting or various lock-and-keymechanisms such as one that may include a combination or series ofgrooves and ridges or bars that match and interlock on a connector.

The releasing function may be performed by an O-ring connection, amagnetic connector, a chuck release mechanism, or a ball and detentmechanism with and without a spring. In one embodiment the releasingfunction may occur by means of a trigger mechanism whereby a triggercomes in contact with a holding mechanism and releases a penetrator orneedle. In another embodiment a connecting mechanism may also include atrigger or retractable shield rod that slides up and contacts a holdingmechanism or clamp that breaks away and releases a penetrator or needleafter contact (not expressly shown).

FIGS. 6A-C illustrate alternate embodiments of connectors operable toreleasably attach penetrator assembly 55 to powered drill apparatus 10.FIG. 6A illustrates penetrator assembly connector 62 wherein connector62 is formed to fit into a connector receptacle 64 and releasably lockinto place. In this example, connector 62 and connector receptacle 64are pentagonal shaped. Advantages of this embodiment may be the ease ofattachment and removal of penetrator assembly 55 from powered drillapparatus 10. Penetrator assembly connector 62 may be formed from metalor plastic.

FIG. 6B illustrates an alternate embodiment of penetrator assemblyconnector wherein a female pentagonal receptacle 65 is operable toengage pentagonal connecting piece 66 attached to powered drillapparatus 10. FIG. 6C illustrates a further embodiment of a penetratorassembly connector wherein penetrator assembly connector 68 is aproprietary design having a pattern of ridges or bars 73 that engage amatching pattern of slots 71 on a connecting receptacle 72. Examplepenetrator assembly connectors may include any type of lock and keydesign or a pentagonal design. Penetrator assembly connectors of anytype may be held in place by either a magnet, an O-ring connector or aball and detent mechanism with or without a spring (not expresslyshown).

In one embodiment, the penetrator assembly may include an outerpenetrator such as a cannula, needle or hollow drill bit which may be ofvarious sizes. Needles may be small (for pediatric patients), medium(for adults) and large (for over-sized adults). Penetrator, cannulas orneedles may be provided in various configurations depending on theclinical purpose for needle insertion. For example, there may be oneconfiguration for administering drugs and fluids and an alternateconfiguration for sampling bone marrow or for other diagnostic purposesalthough one needle configuration may be suitable for both purposes.Needle configuration may vary depending on the site chosen for insertionof a needle.

FIGS. 7A-7D illustrate one embodiment of a penetrator assembly 80 thatincludes a removable inner trocar 82 and an outer penetrator 84. FIG. 7Billustrates a cross-sectional view of one embodiment of a penetratorassembly having a removable inner trocar 82 and an outer penetrator 84.Outer penetrator 84 includes flange 86 and flange groove 88. Flange 86may be used to stabilize penetrator assembly 80 against the skin of aninsertion site. Flange groove 88 is operable to engage plasticpenetrator cover 94. The surface of outer penetrator may include aseries of discs formed along a longitudinal axis, a series of ridges orsome other grasping means. This surface allows an operator to grasp theouter penetrator with two fingers and easily disengage the inner trocar82 from outer penetrator 84. Outer penetrator 84 includes a penetratorcannula 96 that is hollow when stylet 100 is removed.

In FIG. 7C inner trocar 82 includes handle 98 that may have a surfacesuch as a series of discs formed along a longitudinal axis of thetrocar, or a series of ridges or some other grasping means. Handle 98allows an operator to easily grasp and manipulate inner trocar 82 anddisengage it from outer penetrator 84. Inner trocar 82 also includesstylet 100. Stylet 100 exits an end of penetrator cannula 96 when innertrocar 82 is inserted into outer penetrator 84 Stylet 100 includes acutting tip and is operable to penetrate bone marrow. In one embodimentof the invention, inner trocar 82 may include metal disc 95 to allow amagnetic connection between penetrator assembly and powered drill.Receptacle 97 may also engage a penetrator assembly male-type connectorpiece operable to connect penetrating assembly to a powered drill, orany other suitable connector.

FIGS. 7E-7G illustrate example release mechanisms that may be coupled toa connector and included in penetrator assembly 80. FIG. 7E illustratesone embodiment of a magnetic release mechanism where magnetic disc 70 isincluded in inner trocar 82. In this embodiment magnetic disc 70 is atthe base of open area or receptacle 97. In alternative embodiments amagnetic disc could be included with a pentagonal connector or a lockand key connector or any other suitable connector.

FIG. 7F illustrates another embodiment of a release mechanism whereO-ring 72 is included in trocar 98 as part of a connector. In thisembodiment O-ring 72 is in the wall of receptacle 97. O-ring 72 is ableto engage a lock and key connector, a pentagonal connector or any othersuitable connector.

FIG. 7G illustrates yet another embodiment of a release mechanism usingball and detent mechanism 74. In this embodiment ball and detentmechanism 74 is in the wall of receptacle 97. Ball and detent mechanism74 is able to engage a lock and key connector, a pentagonal connector orany other suitable connector.

FIG. 8A illustrates an embodiment of an outer penetrator needle 110 andinner stylet 112. Cutting tip 114 of outer penetrator needle 110 and tipof inner stylet 112 are operable to penetrate bone marrow. In oneembodiment of the invention the outer penetrator needle and the innerstylet are ground together as one unit in the manufacturing process toensure that the two pieces are an exact fit and act as a single drillingunit.

FIG. 8B illustrates another embodiment of an outer penetrator needle 96and an inner stylet 100. Cutting tip 102 of inner stylet 100 is operableto penetrate bone marrow. Inner stylet may also include a longitudinalgroove 104 that runs along the side of stylet 100 that allows bone chipsand tissue to exit an insertion site as a penetrator assembly is drilleddeeper into bone. Outer penetrator or needle 96 includes cutting tip 106that facilitates insertion of outer penetrator or needle 96 andminimizes damage to outer penetrator or needle 96 as penetrator assembly55 is inserted into bone marrow. In one embodiment of the invention theouter penetrator needle and the inner stylet are ground together as oneunit in the manufacturing process to ensure that the two pieces are anexact fit and act as a single drilling unit.

FIG. 9 illustrates one embodiment of kit 120 to penetrate bone marrow.Kit 120 includes apparatus 10 for penetrating bone marrow, alternativesizes of penetrator assemblies 122, and strap 124 suitable to immobilizean outer penetrator on an extremity during insertion of penetratorassembly 122. Carrying case 125 is also included.

Once an outer penetrator or needle is inserted into a bone, it may beconnected to a source of intravenous fluids or medication. FIG. 10illustrates an example of a connector that may be used to connect theouter penetrator of a penetrator assembly to tubing 130, for example anintravenous tubing for providing intravenous fluids or medications to aperson. Outer penetrator 84 is inserted into the bone marrow of anextremity. Right angle connector 132 is then used to connect intravenoustubing 130 to outer penetrator 84. Right angle connector has theadvantage of allowing tubing to be connected to an outer penetrator orneedle at an angle that will not kink or pinch off the lumen of thetubing. Other connectors or adapters may also be used to connect anouter penetrator to an intravenous tubing, another kind of tubing or toa syringe for use in providing medication or fluids to a person or foruse in withdrawing a sample of blood from the bone marrow.

A method for providing access to the bone marrow includes using apowered drill, capable of reciprocal or rotational motion, to insert apenetrator assembly that includes an outer penetrator and an innertrocar into a bone marrow cavity. The powered drill is then releasedfrom the penetrator assembly and the inner trocar is grasped and removedfrom the outer penetrator. A connector present on the end of the outerpenetrator, for example a luer lock connector, is then available forattachment to either an adapter, such as a right angle connector ordirectly to an intravenous tubing or syringe.

Various features of the present disclosure may also be described withrespect to powered drivers 1030 and 1030 a-1030 f. Various features ofthe present disclosure may also be described with respect tointraosseous devices such as shown in FIGS. 18A and 18B. However, thepresent disclosure is not limited to use with intraosseous device 1160or powered drivers 1030 and 1030 a-1030 f.

Powered driver 1030 as shown in FIGS. 11A, 11B and 13A may besatisfactorily used to insert an intraosseous device at a desiredinsertion site adjacent to a bone and associated bone marrow (notexpressly shown). For embodiments such as shown in FIGS. 11A, 11B and13A powered driver 1030 may include one or more features of the presentdisclosure including, but not limited to, a light operable to illuminatean insertion site, charging contacts and associated charging circuitry,a power supply status indicator, trigger guard, variable speedcontroller, safety switch and/or timing circuit. At least one or more ofthe preceding features and/or additional features of the presentdisclosure may also be shown with respect to powered drivers 1030-1030 fand/or 1330 a-1330 k.

Various components associated with powered driver 1030 may be disposedwithin housing 1032. For example a power source such as rechargeablebattery pack 1034 may be disposed within handle 1036. Battery pack 1034may have various configurations and may include multiple batteriesdisposed within sealed packaging material. For other applications, anon-rechargeable battery pack may also be disposed within handle 1036.

Handle 1036 may be generally described as an elongated, hollow containersized to receive battery pack or power supply 1034. Cap 1038 may bedisposed on one end of handle 1036. Cap 1038 may be removed to allowinserting and removing battery pack 1034 therefrom. Handle 1036 may alsoinclude finger grips 1064 having generally ergonomic configurations.

For embodiments such as shown in FIGS. 11A, 11B and 13A cap 1038 mayinclude a pair of charging contacts 1040 a and 1040 b. A portion of eachcontact 1040 a and 1040 b may extend from cap 1038 for engagement withan appropriate charging receptacle. See FIG. 13A. For some applicationscap 1038 and adjacent portions of handle 1036 may have heavy duty screwon or thread connections (not expressly shown). For some applicationscap 1038 may be formed from relatively strong, heavy duty polymericmaterial.

Motor 1044 and gear assembly 1046 may also be disposed within portionsof housing 1032 adjacent to handle 1036. For embodiments represented bypowered drivers 1030-1030 e and 1330 a-1330 k, motor 1044 and gearassembly 1046 may be generally aligned with each other. Motor 1044 maybe connected with one end of gear assembly 1046. Drive shaft 1052 may beengaged with and extend from another end of gear assembly 1046 oppositefrom motor 1044.

For some applications both motor 1044 and gear assembly 1046 may havegenerally cylindrical configurations. Exterior portion 1045 of motor1044 may correspond with the largest nominal outside diameter associatedwith motor 1044. Exterior portion 1047 of gear assembly 1046 maycorrespond with the largest nominal outside diameter associated withgear assembly 1046. For embodiments of the present disclosurerepresented by powered drivers 1030-1030 e and 1330 a-1330 k, exteriorportion 1047 of gear assembly 1046 may represent a nominal outsidediameter portion larger than any other outside diameter portionassociated with motor 1044. In other embodiments of the presentdisclosure represented by powered driver 1330 i, exterior portion 1047of gear assembly 1046 may be smaller than outside diameter portionsassociated with impact device 1044 a.

Portions of housing 1032 may have generally similar cylindricalconfigurations corresponding with exterior portions of motor 1044 andgear assembly 1046. For example, segment 1032 a of housing 1032 may havea generally cylindrical, hollow configuration with an inside diametercompatible with exterior portion 1045 of motor 1044. Housing segment1032 b may have a generally cylindrical, hollow configuration with aninside diameter compatible with exterior portion 1047 of gear assembly1046. Since portions of gear assembly 1046 have an outside diameter thatis larger than the outside diameter of motor 1044, housing segment 1032b may have a larger outside diameter than the outside diameter ofhousing segment 1032 a.

Motors and gear assemblies satisfactory for use with a powered driverincorporating teachings of the present disclosure may be obtained fromvarious vendors. Such motor and gear assemblies are typically ordered as“sets” with one end of each motor securely attached to an adjacent endof an associated gear assembly. The gear assemblies may sometimes bereferred to as “reduction gears” or “planetary gears”.

A drive shaft having desired dimensions and configuration may extendfrom the gear assembly opposite from the motor. The drive shaft may beprovided as part of each motor and gear assembly set. The dimensionsand/or configuration of an associated housing may be modified inaccordance with teachings of the present disclosure to accommodatevarious types of motors, gear assemblies and/or drive shafts. Forexample, powered drivers used with aspiration needles and/or biopsyneedles may include gear assemblies with larger dimensions required toaccommodate larger speed reduction ratios, for example between 60:1 and80:1, resulting in slower drive shaft RPM. Powered drivers used toprovide intraosseous access during emergency medical procedures mayoperate at a higher speed and may include gear assemblies having asmaller speed reduction ratio, for example between 10:1 and 30:1,resulting in higher drive shaft RPM. For some applications, thedifference in size for gear assemblies may result in increasing theinside diameter of an associated housing by approximately two to threemillimeters to accommodate larger gear assemblies associated withpowered drivers used to insert biopsy needles and/or aspiration needles.

Distal end or first end 1048 of housing 1032 may include opening 1050with portions of drive shaft 1052 extending therefrom. For someapplications the portion of drive shaft 1052 extending from housing 1032may have a generally pentagonal shaped cross section with taperedsurfaces 1054 disposed thereon. Tapered surfaces 1054 may be disposed atan angle of approximately three (3°) degrees with respect to alongitudinal axis or rotational axis (not expressly shown) associatedwith drive shaft 1052. Relatively small magnet 1056 disposed on theextreme end of drive shaft 1052 opposite from housing 1032. Fittingsand/or connectors with various dimensions and/or configurations otherthan drive shaft 1052 and/or magnet 1056 may also be satisfactorily usedwith a powered driver incorporating teachings of the present disclosure.

Intraosseous devices having corresponding tapered openings or connectorreceptacles may be releasably engaged with portions of drive shaft 1052extending from housing 1032. For example, portions of drive shaft 1052extending from distal end 1048 may be releasably engaged with taperedopening 1186 in connector 1180 as shown in FIGS. 18A and 18B or taperedopening 1156 in connector receptacle 1152 as shown in FIGS. 19 and 20.

For embodiments such as shown in FIGS. 11A, 11B and 13A, powered driver1030 may also include light 1060 disposed adjacent to trigger assembly1062. Electrical circuits and associated wiring contacts may also bedisposed within housing 1032 to supply electrical power to light 1060.Trigger assembly 1062 may be used to activate electrical circuits toprovide electricity from rechargeable battery 1034 to motor 1044 and/orlight 1060. A block diagram showing one example of such electricalcircuits is shown in FIG. 12A.

A block diagram showing one example of electrical circuits and othercomponents which may be satisfactory used with a powered driverincorporating teachings of the present disclosure is shown in FIG. 12A.Various features of the present disclosure may be described with respectto electrical system 1400 as shown in FIG. 12A. Electrical system 1400may include various components such as power supply or battery pack1034, charging contacts 1040 a and 1040 b, motor 1044, light 1060 and/orenable switch 1062. Electrical system 1400 may include a wide variety ofelectrical circuits and electrical components including, but not limitedto, power supply status indicator 1070 and electrical charging circuit1410, voltage regulator 1430 and variable speed controller 1460. Aspreviously noted, power supply or battery pack 1034 may include one ormore rechargeable batteries. Various types of nickel metal hydride(NiMH) batteries may be used (particularly lithium batteries). Batterypack 1034 may supply fourteen (14) to eighteen (18) volts of directcurrent (DC) power. However, a wide variety of chargeable andnon-rechargeable batteries may be satisfactorily used with powereddrivers incorporating teachings of the present disclosure.

A wide variety of electrical circuits and/or electronic indicators maybe used with power supply status indicator 1070. Additional informationconcerning such electrical circuits and displays may be described withrespect to various power supply status indicators as shown in FIGS. 13B,13C and 13D.

A wide variety of charging circuits, voltage regulators and variablespeed controllers may be satisfactorily used with a powered driverincorporating teachings of the present disclosure. Various examples ofsuch charging circuits, voltage regulators and/or variable speedcontrollers are shown in FIGS. 12B and 12C. Various types of commercialavailable charging circuits, voltage regulators and/or variable speedcontrollers may be satisfactorily used with a powered driverincorporating teachings of the present disclosure. Various examples ofcommercially available microcontrollers may be satisfactory for use withvariable speed controller 1460. Variable resistor 1600 a as shown inFIG. 12B and variable resistor 1600 b as shown in FIG. 12C representsexamples of mechanical devices having slidable contacts which may beused to vary current supplied to motor 1044. A trigger assemblyincorporating teachings of the present disclosure may be satisfactoryused to move one or more of the electrical contacts 1602 a or 1602 b.

Switch 1062 may be provided to prevent inadvertent or undesiredactivation of motor 1044. Switch 1062 may prevent discharge of battery1034 when an associated powered device is carried in a backpack and/ormobile storage container. An associated button 1072 a may be disposed onexterior portions of a housing to activate the variable speed controller1460. Button 1072 a may be located at various positions on the exteriorof a housing associated with a powered driver incorporating teachings ofthe present disclosure as shown in FIGS. 15A-15C. A wide variety ofindicators including, but not limited to, light emitting diodes (LED),liquid crystal displays (LCD) and small more conventional light bulbsmay be satisfactorily used with a powered driver according to teachingsof the present disclosure.

FIG. 13A shows one example of a cradle which may be used to recharge apowered driver in accordance with teachings of the present disclosure.Cradles and/or holders incorporating teachings of the present disclosuremay be fabricated from a wide variety of thermoplastic and/or polymericmaterials including, but not limited to, polycarbonates. Such materialsmay be filled with glass fibers or any other fibers satisfactory for usein forming a cradle or holder operable to hold and/or recharge a powereddriver in accordance with teachings of the present disclosure. Nylonfilled with glass may be used for some applications.

Materials used to form cradle 1280 may be relatively low cost butdurable. Such materials may be relatively stiff to secure a powereddriver therein and may also flex without breaking to allow inserting andremoving a powered driver at least five hundred (500) times.

Cradle 1280 may have a length and width selected to be compatible withexterior portions of housing 1032 and corresponding dimensions ofpowered driver 1030. For some applications first end 1281 and second end1282 may have generally rounded configurations. A notch (not expresslyshown) may also be formed in first end 1281 to accommodate portions ofdrive shaft 1052. Various types of holders, clamps or quick releasemechanisms may be included as part of cradle 1280. For embodiments suchas shown in FIG. 13A, cradle 1280 may include a pair of arms 1284projecting from respective edges of cradle 1280. Only one arm 1284 isshown in FIG. 13A.

Arms 1284 may be relatively strong with sufficient flexibility to allowinserting and removing portions of powered driver 1030 from engagementwith cradle 1280. The height of arms 1284 relative to adjacentlongitudinal edges of cradle 1280 may be based at least in part on thecorresponding dimensions of handle 1036 and other portions of housing1032. The spacing or gap formed between arms 1284 may be selected toaccommodate the width of handle 1036. Respective rib 1286 may be formedon the end of each arm 1284. The configuration of ribs 1286 may beselected to be compatible with a snug but releasable snap fit withadjacent portions of handle 1036.

For some applications walls or partitions 1290 may be formed adjacent torespective arms 1294. Only one wall 1290 is shown in FIG. 13A.Partitions or walls 1290 may be spaced from each other a sufficientdistance to accommodate associated portions of housing 1032 and may besized to prevent accidental activation of trigger assembly 1062.

End 1282 of cradle 1280 may be modified to include electrical contact(not expressly shown) operable to engage recharging contacts 1040 a and1040 b. Electric power cable 1292 may also extend from end 1282.Electrical power cable 1292 may be inserted into an appropriateelectrical outlet for use in recharging powered driver 1030. A pluralityof lights 1296, 1298 and 1300 may be provided on exterior portions ofcradle 1300 to indicate the status of rechargeable battery 1034. Forexample light 1296 may indicate red when rechargeable battery 1034 isdischarged below a desired level. Light 1298 may be flashing yellow toindicate that rechargeable battery 1034 is being recharged and/ordischarged. Light 1300 may be steady green to indicate when rechargeablebattery 1034 has been fully recharged. Lights 1296, 1298 and 1300 mayalso alternately blink or have a steady state condition.

Powered drive 1030 a as shown in FIG. 13B may include an indicatoroperable to indicate the status of a power supply disposed within handle1036. For some embodiments status indicator 1070 a may be disposed atproximal end or second end 1049 a of powered driver 1030 a. A digitaldisplay indicating the number of insertions available from a powersupply disposed within housing 1032 a may be provided by indicator 1070at proximal end 1049 a of housing 1032 a. The power supply may be anytype of battery or other suitable source of power.

An embodiment of the present disclosure is shown in FIG. 13C whichincludes status indicator 1070 b disposed on second end or proximal end1049 b of powered driver 1030 b. Status indicator 1070 b may includedigital indication 1072 showing the number of insertions remaining in anassociated power source. In addition variable indicator scale 1074 maybe provided to show the status of an associated power source betweenfully charged and recharge required. For example, variable indicatorscale 1074 may include a voltmeter, an amp meter, and/or any othercomponent operable to measure the status of an associated power supply.As another example, variable indicator scale 1074 may be calibrated todisplay a percentage of full charge and/or a number of insertionsremaining.

A further embodiment of the present disclosure is shown in FIG. 13D. Forthis embodiment lights 1296, 1298 and 1300 may be disposed on proximalend or second end 1049 c of powered driver 1030 c. Lights 1296, 1298 and1300 may function as previously describe with respect to cradle 1280.

FIGS. 17A and 17B show another embodiment of the present disclosureincluding powered driver 1330 j disposed within cradle 1280 a. Cradle1280 a may include arms 1284 a as described in relation to FIG. 13b .Arms 1284 a may be relatively strong with sufficient flexibility toallow inserting and removing portions of powered driver 1330 j fromengagement with cradle 1280 a. The height of arms 1284 a relative toadjacent longitudinal edges of cradle 1280 a may be based at least inpart on the corresponding dimensions of handle 1336 and other portionsof housing 1332. The spacing or gap formed between arms 1284 may beselected to accommodate the width of handle 1336.

Powered drivers 1030 d and 1030 e as shown in FIGS. 14A and 14B showalternative locations for a light disposed on a powered driver inaccordance with teachings of the present disclosure. Powered driver 1030d may include substantially the same features as powered driver 1030except light 1060 d may be disposed on housing segment 1032 b oppositefrom trigger assembly 1062. For embodiments such as shown in FIG. 14Blight 1060 e may be disposed on distal end or first end 1048 e ofpowered driver 1030 e. Light 1060 e may extend approximately threehundred sixty degrees (360°) around the perimeter of associated driveshaft 1054.

A further embodiment of a rechargeable powered driver incorporatingteachings of the present disclosure is shown in FIG. 14C. Forembodiments represented by powered driver 1030 f, cap 1038 f may bedisposed on one end of handle 1036. Cap 1038 may include opening 1040sized to receive charging connection 1130 attached to power cable 1132.A wide variety of recharging connectors may be used to provide power tocable 1132.

FIGS. 16A and 16B show examples of a protective covering 1063 fortrigger assembly 1062 or switch assembly 1062 of powered driverincorporating teachings of the present disclosure. Housing 1032 may besealed to prevent blood, other bodily fluids, and/or other contaminantsfrom reaching interior portions of housing 1032 and components disposedtherein (e.g., battery 1034, motor 1044, and/or gear assembly 1046).FIGS. 16A and 16B show protective covering 1063 a and 1063 b configuredto seal with housing 1032. Protective covering 1063 a and 1063 b may beformed with an elastomeric material chosen for resistance to wear,electrical current, impermeability, and/or any other characteristicsought as long as it allows operation of switch assembly 1062 by theuser.

FIG. 16C shows powered driver 1330 i incorporating an impact device 1044a associated with gearbox 1046 and power sensor circuit 1600 c. Impactdevice 1044 a may be configured to operate in a similar manner to animpact wrench by storing energy in a rotating mass then delivering itsuddenly to gearbox 1046. In some embodiments, impact device 1044 a willrequire less total power from power supply 1034.

Power sensor circuit 1600 c may detect current changes between impactdevice 1044 a and power supply 1034. In some applications, currentchanges between impact device 1044 a and power supply 1034 may indicatebone penetration is complete. Power sensor circuit 1600 c may beoperable to automatically reduce or cut power from power supply 1034 toimpact device 1044 a once the associated intraosseous device haspenetrated the cortex of the bone.

An intraosseous device (IO), sometimes referred to as a penetratorassembly or IO needle set, may include an outer penetrator such as acannula, needle or hollow drive bit which may be of various sizes.Needles may be small (for pediatric patients), medium (for adults) andlarge (for over-sized adults). Penetrator, cannulas or needles may beprovided in various configurations depending on the clinical purpose forneedle insertion. For example, there may be one configuration foradministering drugs and fluids and an alternate configuration forsampling bone marrow or for other diagnostic purposes although oneneedle configuration may be suitable for both purposes. Needleconfiguration may vary depending on the site chosen for insertion of aneedle.

A wide variety of trocars, spindles and/or shafts may be disposed withina catheter or cannula during insertion at a selected insertion site.Such trocars, spindles and shafts may also be characterized as innerpenetrators. A catheter, cannula, hollow needle or hollow drive bit maysometimes be characterized as an outer penetrator.

For some applications a layer or coating (not expressly shown) of ananticoagulant such as, but not limited to, heparin may be placed oninterior and/or exterior portions of a catheter or cannula to preventthrombotic occlusion of the catheter or cannula. Anticoagulants mayreduce platelet adhesion to interior surfaces of the catheter or cannulaand may reduce clotting time of blood flowing into and through thecatheter or cannula. Placing a layer of an anticoagulant on exteriorportions of a catheter or cannula adjacent to an associated tip and/orside ports may be helpful to prevent clotting.

Penetrator assembly 1160 as shown in FIGS. 18A and 18B may includeconnector 1180, and associated hub 1200, outer penetrator 1210 and innerpenetrator 1220. Penetrator assembly 1160 may include an outerpenetrator such as a cannula, hollow tube or hollow drive bit and aninner penetrator such as a stylet or trocar. Various types of styletsand/or trocars may be disposed within an outer penetrator. For someapplications outer penetrator or cannula 1210 may be described as agenerally elongated tube sized to receive inner penetrator or stylet1220 therein. Portions of inner penetrator 1220 may be disposed withinlongitudinal passageway 1184 extending through outer penetrator 1210.The outside diameter of inner penetrator 1220 and the inside diameter oflongitudinal passageway 1184 may be selected such that inner penetrator1220 may be slidably disposed within outer penetrator 1210.

Metallic disc 1170 may be disposed within opening 1186 for use inreleasably attaching connector 1180 with magnet 1056 disposed on the endof drive shaft 1052. End 1223 of inner penetrator 1220 is preferablyspaced from metallic disc 1170 with insulating or electricallynonconductive material disposed therebetween.

Tip 1211 of outer penetrator 1210 and/or tip 1222 of inner penetrator1220 may be operable to penetrate bone and associated bone marrow. Theconfiguration of tips 1211 and/or 1222 may be selected to penetrate abone or other body cavities with minimal trauma. First end or tip 1222of inner penetrator 1220 may be trapezoid shaped and may include one ormore cutting surfaces. In one embodiment outer penetrator 1210 and innerpenetrator 1220 may be ground together as one unit during an associatedmanufacturing process. Providing a matching fit allows respective tips1211 and 1222 to act as a single driving unit which facilitatesinsertion and minimizes damage as portions of penetrator assembly 1160are inserted into a bone and associated bone marrow. Outer penetrator1210 and/or inner penetrator 1220 may be formed from stainless steel,titanium or other materials of suitable strength and durability topenetrate bone.

Hub 1200 may be used to stabilize penetrator assembly 1160 duringinsertion of an associated penetrator into a patient's skin, soft tissueand adjacent bone at a selected insertion site. First end 1201 of hub1200 may be operable for releasable engagement or attachment withassociated connector 1180. Second end 1202 of hub 1200 may have a sizeand configuration compatible with an associated insertion site for outerpenetrator 1210. The combination of hub 1200 with outer penetrator 1210may sometimes be referred to as a “penetrator set” or intraosseousneedle.

Connector 1180 and attached inner penetrator 1220 may be releasablyengaged with each other by Luer type fittings, threaded connections orother suitable fittings formed on first end 1201 of hub 1200. Outerpenetrator 1210 extends from second end 1202 of hub 1200.

For some applications connector 1180 may be described as a generallycylindrical tube defined in part by first end 1181 and second end 1182.The exterior of connector 1180 may include an enlarged tapered portionadjacent to end 1181. A plurality of longitudinal ridges 1190 may beformed on the exterior of connector 1180 to allow an operator to graspassociated penetrator assembly 1160 during attachment with a driveshaft. See FIG. 18B. Longitudinal ridges 1190 also allow connector 1180to be grasped for disengagement from hub 1200 when outer penetrator 1210has been inserted into a bone and associated bone marrow.

Second end 1182 of connector 1180 may include opening 1185 sized toreceive first end 1201 of hub 1200 therein. Threads 1188 may be formedin opening 1185 adjacent to second end 1182 of connector 1180. Threadedfitting 1188 may be used in releasably attaching connector 1180 withthreaded fitting 1208 adjacent to first end 1201 of hub 1200.

First end 1201 of hub 1200 may include a threaded connector 1208 orother suitable fittings formed on the exterior thereof. First end 1201may have a generally cylindrical pin type configuration compatible withreleasably engaging second end or box end 1182 of connector 1180.

For some applications end 1202 of hub 1200 may have the generalconfiguration of a flange. Angular slot or groove 1204 sized to receiveone end of protective cover or needle cap 1234 may be formed in end1202. Slot or groove 1204 may be used to releasable engage a needlecover (not expressly shown) with penetrator assembly 1160.

For some applications a penetrator assembly may include only a single,hollow penetrator. For other applications a penetrator assembly mayinclude an outer penetrator such as a cannula, hollow needle or hollowdrive bit and an inner penetrator such as a stylet, trocar or otherremovable device disposed within the outer penetrator. Penetrator 1210is one example of a single, hollow penetrator.

The size of a penetrator may vary depending upon the intendedapplication for the associated penetrator assembly. Penetrators may berelatively small for pediatric patients, medium size for adults andlarge for oversize adults. By way of example, a penetrator may range inlength from five (5) mm to thirty (30) mm. The diameter of a penetratormay range from eighteen (18) gauge to ten (10) gauge. The length anddiameter of the penetrator used in a particular application may dependon the size of a bone to which the apparatus may be applied. Penetratorsmay be provided in a wide variety of configurations depending uponintended clinical purposes for insertion of the associated penetrator.For example, there may be one configuration for administering drugsand/or fluids to a patient's bone marrow and an alternativeconfiguration for sampling bone marrow and/or blood from a patient.Other configurations may be appropriate for bone and/or tissue biopsy.

For some applications connector 1180 may be described as having agenerally cylindrical configuration defined in part by first end 1181and second end 1182. See FIG. 18B. Exterior portions of connector 1180may include an enlarged tapered portion adjacent to end 1181. Aplurality of longitudinal ridges 1190 may be formed on the exterior ofconnector 1180 to allow an operator to grasp associated penetratorassembly 1160 during attachment with a drive shaft. Longitudinal ridges1190 also allow connector 1180 to be grasped for disengagement from hub1200 when outer penetrator 1210 has been inserted into a bone andassociated bone marrow.

First end 1181 of connector of 1180 may include opening 1186 sized toreceive portions drive shaft 1052 therein. A plurality of webs 1136 mayextend radially outward from connector receptacle 1186. Webs 1136cooperate with each other to form a plurality of openings 1138 adjacentto first end 1181. Opening 1186 and openings 1138 cooperate with eachother to form portions of a connector receptacle operable to receiverespective portions of connector 1030 therein. FIGS. 19A and 19B showisometric views of embodiments of connector 1180 a and hub 1200 a.

A wide variety of accessory tools and devices are frequently carried byemergency medical service personnel and/or first responders. Pumpassembly 1130 as shown in FIG. 20 represents an example of an accessorytool which may be operated by a powered driver incorporating teachingsof the present disclosure. Pump assembly 1130 may include housing 1134with connector receptacle 1152 extending therefrom. Various componentsof pump assembly 1130 (not expressly shown) may be disposed withinhousing 1134 and rotatably attached with connector receptacle 1152.Inlet tubing 1131 may be provided to communicate fluids with interiorportions of pump housing 1134. Outlet tubing 1132 may be provided todirect fluids exiting from pump assembly 1130. Such fluids may bevarious types of liquids associated with medical procedures. Such fluidsmay include small particulate matter. Pump assembly 1130 may sometimesfunction as a vacuum or suction pump for such procedures.

First end 1154 of connector receptacle 1152 may include opening 1156similar to opening 1186 as described with respect to connector 1180. End1252 extending from power driver 1230 a may be disposed within opening1156 to rotate connector receptacle 1152 and attached components of pumpassembly 1130 a. As a result, powered driver 1230 a may be used to pumpfluids from inlet 1131 through pump assembly 1130 a and outwardly fromoutlet 1132.

One embodiment of the device calls for it being disposable. Anotherembodiment is designed for the body (driver) to be reusable and theneedle to be disposable. This is made possible by providing a chuck thatmates with a proprietary shaft attached to the needle's Luer lock. Theneedles must maintain sterility during storage and mounting of theneedle while the driver does not have to be sterile. The driver will berugged in design and the battery (or other power source) will berechargeable or the battery will be easy to replace with off-the-shelfbatteries.

FIG. 21 shows the configuration of a driver without a needle inserted. Ahousing 2014 and a trigger 2015 are shown. A battery indicator 2040 isalso shown.

FIG. 22 shows the motor 2011, gearbox 2017, gear 2018, and battery 2010of the reusable driver. It also shows the chuck 2037, which is designedto accept the keyed needle or “unit dose” ampule. It is important in thereusable design to have a rechargeable battery or the ability to easilychange off-the-shelf batteries i.e. a 9-volt battery. It may alsoincorporate a battery level indicator or other battery reserve indicator(not expressly shown).

The present disclosure includes a wide variety of kits, devices andassociated components which may be used to obtain vascular access to apatient. In some embodiments, such kits may include apparatus operableto access a patient's bone marrow using a driver, an intraosseous needleand one or more connectors to communicate fluids with the patient's bonemarrow. Such kits may also include apparatus which allows monitoring apatient.

Kits incorporating teachings of the present disclosure may be rigid,semi-rigid or soft-sided. Such kits may provide a convenient way tocarry various components and devices operable to achieve vascular accessin an organized and systematic fashion. Such kits may present EMS firstresponders and other medical personnel with a well organized collectionof components and devices to achieve vascular access by placement ofperipheral intravenous (IV) catheters and/or intraosseous (TO)catheters. For some embodiments, a kit incorporating teachings of thepresent disclosure may be combination an IV kit, an IO kit and/or a unitdose kit in one convenient bag. Examples of various types of devices andcomponents which may be carried in a kit in accordance with teachings ofthe present disclosure are shown in FIGS. 29A-41.

Securing devices incorporating teachings of the present disclosure maybe provided in kits to allow easy removal and replacement of associateddrivers. Such securing devices may include a wide variety of cradles andother types of holder's with relatively rugged snap-in features toprevent undesired release of a driver from an associated securingdevice. Securing devices may be formed from plastic and/or glasscomposite materials to provide durability for repeated replacement anduse of an associated driver. Such securing devices may releasably holdan associated driver in place within a kit so that the driver does notinterfere with other devices and components disposed in the kit. Asecuring device may be positioned in a kit to clearly present anassociated driver to a user during consideration of alternate vascularaccess routes.

Securing devices incorporating teachings of the present disclosure maymake it easy for a user to extract an associated driver from a kit usingonly one hand. Other components such as penetrator assemblies and IOneedles may be conveniently located in the kit to further minimize timeand manipulations required for a user to attach an IO needle and insertthe IO needle at a desired site in a patient. Such securing devices mayalso provide an easy site to return the driver to the kit after use. Theassociated driver may snap into place to securely protect the driveragainst accidental deployment until required for use in presidinganother IO access.

Kits incorporating teachings of the present disclosure may be used inlocations where ruggedness and durability are of paramount importance.Such kits may be washable, water proof, temperature resistant, and/orcrush proof. Such kits may have a wide variety of different shapes andcolors. Kits incorporating teachings of the present disclosure may beany size as required to contain selected IO devices and IV devices whichmay be used to obtain vascular access. In some embodiment kits may beapproximately ten inches in length by six to eight inches in width.

For some applications kits incorporating teachings of the presentdisclosure may be designed for use in military applications. Such kitmay be as compact as feasible with components disposed in one or morecompartments as necessary for an efficient use of space. Such kits mayalso include a manual intraosseous driver and related intraosseouscomponents to access a patient's vascular system. Such kits may includeintraosseous catheters, intravenous catheters, containers with sterilenormal saline, tourniquets and IO/IV securing devices. Variouscomponents may be configured for particular branches of the military,e.g., Army, Navy, Air Force, Coast Guard and Special Forces.

Another benefit of the present disclosure may include forming a kit withone or more dividers having components and devices arranged in order onpage one and page two corresponding with steps of a procedure such astreating a patient with an emergency condition or treating a patient fora chronic condition. The pages in a kit may be arranged to accommodate awide variety of procedures. For example, if a kit will be used in anoncology related application or for treatment of other chronicconditions, the “pages” in the kit may be arranged based on the stepsrequired to provide access to a patient's vascular system and to carryout a planned treatment.

Various techniques and procedures may be used to position and securelyengage a supporting structure for an IO device at an insertion site. Forsome applications, various types of straps may be used. See FIGS. 30 and33-39. Alternatively, various types of medical grade tape and adhesivematerials (not expressly shown) may be used. Also, Velcro strips may beused (see FIGS. 37 and 38).

Some features and benefits of the present disclosure may be describedwith respect to kit 3020 (See FIGS. 23A, 23B, 24A) and kit 3020 a (SeeFIG. 28) and kit 3120 (See FIGS. 29A and 29B). However, the presentdisclosure is not limited to kits with designs, features and/or contentsas shown in FIGS. 23A-41.

For some applications kits 3020, 3020 a and/or 3120 may be semi-rigid orsoft, sided. Kits 3020, 3020 a and 3120 may be formed from a widevariety of materials including, but not limited to, nylon, corduroy typematerials, various types of polymeric and plastic materials. For someapplications kits 3020, 3020 a and/or 3120 may be formed from relativelysoft materials such as canvas, polyesters and similar materials. Forother applications kits incorporating teachings of the presentdisclosure may be relatively rigid and formed from materials such aslightweight aluminum alloys and similar hard materials.

For embodiments such as shown in FIGS. 23A-24A and 28, kits 3020 and3020 a may be formed using compression molded techniques. For otherapplications, kits 3020 and 3020 a may be formed with a foam linerhaving desired configuration and dimensions with an outer layer of sewnfabric. Such foam liners may be designed to protect the contents carriedin the resulting kit from being damaged or crushed. Other alternativelow-cost, and reliable manufacturing techniques may be satisfactorilyused to form kits in accordance with teachings of the presentdisclosure.

For some applications, kits 3020 or 3020 a may be generally described asa two part molded case formed at least in part by compression moldingethylene vinyl acetate (EVA) foam. EVA may be generally described as apolymeric material with some of the characteristics of elastomericmaterials and some characteristics of thermal plastic materials. Howeverkits incorporating teachings of the present disclosure may be formedfrom a wide variety of polymeric materials, elastomeric materials and/orthermoplastic materials.

Kits 3020 and/or 3020 a may have a nominal wall thickness ofapproximately 0.19 inches. Exterior surfaces of kits 3020 and/or 3020 amay be covered by a durable layer of heavy linear polyester or othersuitable material. Interior portions of kits 3020 and/or 3020 a may beformed in part by relatively smooth layers of urethane or relativelysmooth layers of polyvinyl chloride (PVC). Such materials allow interiorportions of kits 3020 and/or 3020 a to be more easily cleaned,particularly after use during an emergency at a field location.

Kits 3020 and/or 3020 a may have two segments or enclosures 3022 and3024 with generally hollow, rectangular configurations and compatibledimensions. As a result first segment 3022 and second segment 3024 maybe releasably engaged with each other to form an enclosure havingdesired dimensions and configurations to efficiently carry IO and IVdevices and components associated with kits 3020 and 3020 a. For someapplications, first segment 3022 and second segment 3024 may haveapproximately the same dimensions and configurations such that eachsegment 3022 and 3024 may form approximately one-half of the resultingkit. For applications such as shown in FIGS. 23A-24A and 28, firstsegment 3022 may have a greater height or depth as compared with secondsegment 3024. Interior portions of first segment 3022 may be sized tocontain intravenous fluid bags, intravenous tubing and extension tubing,various types of connectors, syringes and Lidocaine or otheranesthetizing agents.

For purposes of describing various features of the present disclosure,first segment 3022 may be described as having generally rectangularbottom layer or base 3030 with respective pairs of walls 3034 and 3036extending therefrom. Base 3030 may also include first surface orinterior surface 3031 (See FIGS. 24A and 28) and a second, exteriorsurface (not expressly shown). One wall 3034 a of kit 3020 a may bemodified as compared to corresponding wall 3034 of kit 3020. Wall 3034 awill be discussed later in more detail. Generally rounded corners 3038may be formed between adjacent walls 3034 and 3036.

Second segment 3024 may be defined in part by top layer or cover 3040.Sometimes top layer 3040 may also be referred to as a lid. Top layer3040 may include first surface or interior surface 3041 (See FIGS. 24Aand 28) and second surface or exterior surface 3042 (See FIG. 23A).Respective pairs of walls 3044 and 3046 may extend from top layer 3040.Respective rounded corners 48 may be formed between adjacent walls 3044and 3046.

For some applications, a pair of zippers 3028 and 3029 may be used toreleasably engage second segment 3024 with first segment 3022 whenassociated kits 3020 or 3020 a is in their respective first, closedposition. (See FIG. 23A). For other applications a single zipper may besatisfactorily used. For some applications a fluid seal (not expresslyshown) may be formed when the perimeter of first enclosure 3022 isengaged with the perimeter of second enclosure 3024 when kits 3020and/or 3020 a are in their first, closed position.

First segment 3022 and second segment 3024 may be hinged with each otheralong one side of respective kits 3020 and 3020 a. Fabric type hinge3058 or other suitable low cost, reliable hinge mechanism may be used toallow movement of second segment 3024 relative to first segment 3022 toopen and close the associated kit 3020 or 3020 a. Handle 3026 may beattached with exterior portion of kits 3020 and 3020 a opposite from thehinge 3058 located on interiors of kits 3020 and 3020 a. Handle 3026 maybe formed from lightweight, durable web type material or any othersuitable material.

Zippers 3028 and 3029 may be moved around the three edges of contactbetween first enclosure 3022 and second enclosure 3024 to engage anddisengage adjacent portions of enclosures 3022 and 3024. Zippers 3028and 3029 and associated zipper mechanisms may be formed from durable,rustproof material and extend along three edges of contact between firstenclosure 3022 and second enclosure 3024.

After kits 3020 and/or 3020 a have been used at a field location or at amedical facility, the used kit may be returned to a central location forcleaning and replacement of any missing components or devices. For someapplications breakable seal 3023 (See FIG. 23B) may be engaged withzippers 3028 and 3029 to indicate that the associated kit 3020 or 3020 ahas been cleaned, inspected, any missing components or devices replacedand is now ready to be used to provide access to a patient's vascularsystem.

One or more panels or dividers may be disposed within kits incorporatingteachings of the present disclosure. The dividers may also be referredto as “boards.” For embodiments represented by kits 3020 and 3020 a oneedge of each divider 3050 may be engaged with associated hinge 3058 toallow rotating movement of each divider 3050 relative to hinge 3058 whenassociated kit 3020 or 3020 a is in its first, open position.

Dividers 3050 may be formed from polyvinyl chloride (PVC) or othersuitable materials. Each divider 3050 may have a generally rectangularconfiguration with dimensions compatible with nesting each dividerwithin segments 3022 and 3024 when associated kit 3020 or 3020 a is inits first, closed position. For some applications dividers 3050 may beabout 0.050 to 0.060 inches thick. The width and other characteristicsof hinge 3058 may also be selected to accommodate nesting of eachdivider 3050 within segments 3022 and 3024 when associated kit 3020 or3020 a is in its first closed position.

Each divider 3050 may also include first surface 3051 and a secondsurface 3052. Surfaces 3051 and 3052 may sometimes be referred to as“pages.” For embodiments such as shown in FIGS. 24A, 24B and 28, firstsurface 3051 or page 1 and second surface 3052 or page 2 may include aplurality of holders such as elastic straps or bands 3054 and pockets3056. Velcro type straps, holders and elastic bands may also be used.

For example, “page one” or first surface 3051 of divider 3050 maypresent EMS personnel with devices, components and instructions used toselect and clean a site for vascular access. Such components and devicesmay include containers 3062 with cleaning fluids, alcohol wipes or otherprep materials, flashlight 3064 and a tourniquet (not expressly shown).Written instructions for selecting an insertion site and/or locating avein may be provided in pockets 3056 on page one.

“Page Two” or second surface 3052 of divider 3050 may include devicesand components that allow EMS personnel to access a patient's vascularsystem via a peripheral vein or an intraosseous route. Such componentsmay include intravenous catheters, intraosseous needles and othercomponents that may be used to access a patient's vascular system. Asshown in FIG. 24B, one or more containers 3230 with respective IOdevices disposed therein may be releasably engaged with second surface3052 or page two of divider 3050. One or more IV devices such as IVneedle sets 3136 may also be releasably engaged with second surface3052. Each IV needle set 3136 may include a syringe, IV needle and coverfor the IV needle.

For some applications, interior surface 3041 of cover 3040 may alsofunction as page three with additional devices, components andinstructions attached thereto. For example, when kits 3020 and/or 3021 aare used in an emergency environment to provide IO access to a patient,interior surface 3041 or page three may include devices and componentsused to secure and intraosseous device and/or an IV device at theinsertion site and to further prepare the patient for movement to an EMStreatment facility. Components and devices such as tape, dressingmaterials, an arm-board or splint and other components operable tosecure a catheter or an intraosseous line may be provided on page three.Various types of straps and supporting structures for IO devices may bereleasably attached to page three or interior surface 3041. See someexamples in FIGS. 30-39.

Outside pocket 3060 formed from mesh type material may be attached toexterior surface 3042 of cover 3040. Outside pocket 3060 may holdprinted reference materials such as quick reference cards. For someapplications elastic cords (not expressly shown) may also be provided onexterior portion of kits 3020 and 3020 a to hold such materials.

Velcro or elastic strips or loops or any other fastening device may beused to position components on dividers 3050. In lieu of dividers 3050,IO and IV devices and related components may be configured in some otherarrangement or organizing mechanism such as compartments or smallercontainers carried in a kit.

A device for accessing an intraosseous space such as a powered driver(See FIG. 26) or a manual driver (See FIGS. 40A and 41) may be carriedin first segment 3022. For some applications a securing device such asshown in FIGS. 24A, 25, 27 and 28 may be disposed within first segment3022 to releasably hold a driver. For other applications a powereddriver and/or manual driver may be placed in a collapsible bag or pouchand placed within first segment 3022 or other portions of kit 3020and/or 3020 a. For still other applications a powered driver and/ormanual driver may be carried in a bag or pouch attached to exteriorportions (not expressly shown) of kit 3020 and/or 3020 a.

Powered driver 3200 may include housing 3202 with various types ofmotors and/or gear assemblies disposed therein (not expressly shown). Arotatable shaft (not expressly shown) may be disposed within housing3202 and connected with a gear assembly. Various types of fittingsand/or connectors may be disposed proximate one end of the rotatableshaft extending from end 3204 of housing 3202. For some applications apin type fitting or connector such as drive shaft 3216 may be used. Amatching box type fitting or connector receptacle may be provided on anintraosseous device such that power driver 3200 may be releasablyengaged with the intraosseous device. For some applications, drive shaft3236 may have a pentagonal shaped cross section with tapered surfacesformed on the exterior thereof. Fittings and/or connections with variousdimensions and configurations may be satisfactorily used to releasablyengage an intraosseous device with a powered driver.

Container 3230 as shown in FIGS. 24B and 40B may include lid 3232 alongwith associated tab 3234. Tab 3234 may be configured to be flipped openwith one or more digits of an operator's hand. With lid 3232 open, anoperator may releasably engage a driver with an IO device disposed incontainer 3230. For example, drive shaft 3216 of powered driver 3200 maybe releasably engaged with box type connector or receptacle 3258 ofpenetrator assembly 3240. See FIGS. 26 and 40A. Flexible strap 3236 maybe used to retain lid 3232 with container 3230 after lid 3232 has beenopened.

Handle 3206 may include a battery (not expressly shown) or other powersource. Handle 3205 may also include trigger assembly 3208 for use inactivating powered driver 3200. Examples of powered drivers are shown inU.S. patent application Ser. No. 10/449,503, filed May 30, 2003,entitled “Apparatus and Method to Provide Emergency Access To BoneMarrow,” now U.S. Pat. No. 7,670,328; U.S. patent application Ser. No.10/449,476, filed May 30, 2003, entitled “Apparatus and Method to AccessBone Marrow,” now U.S. Pat. No. 7,699,850; and U.S. patent applicationSer. No. 11/042,912, filed Jan. 25, 2005, entitled “Manual IntraosseousDevice,” now U.S. Pat. No. 8,641,715.

Various types of intraosseous devices, intraosseous needles and/orpenetrator assemblies may be carried in a kit incorporating teachings ofthe present disclosure. See for example FIG. 24B. Intraosseous devices3160 and 3160 a which are shown in FIGS. 30, 33, 34 and 35 may becarried in a kit along with powered driver 3200 and inserted into apatient's bone marrow in accordance with teachings of the presentdisclosure.

For some applications a securing device designed to accommodate one ormore specific types of drivers may be disposed within first segment3022. For other applications more generic types of holders or cradlesmay be placed within first segment 3022. For embodiments such as shownin FIGS. 24A, 25, 27 and 28, securing device or cradle 3080 may bedesigned to accommodate powered drivers such as powered driver 3200.Cradles and holders incorporating teachings of the present disclosuremay be fabricated from a wide variety of thermoplastic and/or polymericmaterials filled with glass fibers.

Length 3082 and width 3084 of cradle 3080 may be selected to becompatible with interior dimensions of first enclosure 3022 and similardimensions associated with a driver that will be releasably engaged withcradle 3080. For some applications first end 3086 and second end 3088may have generally rounded configurations. Notch 3090 may be formed infirst end 3086 to accommodate drive shaft 3216 extending from end 3204of power driver 3200.

First longitudinal edge 3091 and second longitudinal edge 3092 may bespaced from each other and extend generally parallel with each otherbetween first end 3086 and second end 3088. For some applications, ends3086, 3088 and longitudinal edges 3091, 3092 may fit flush with interiorsurface 3031 of bottom layer 3030. Maintaining close contact betweeninterior surface 3031 and adjacent portions of cradle 3080 maysubstantially reduce or minimize problems associated with cleaning anassociated kit after use, particularly after used during an emergency ata field location.

Various types of holders, clamps and/or quick release mechanisms may beprovided on a cradle incorporating teachings of the present disclosure.For embodiments represented by cradle 3080 a pair of arms 3094 and 3096may project from respective longitudinal edges 3091 and 3092. Arms 3094and 3096 may be relatively strong with sufficient flexibility to allowinserting and removing portions driver 3200 from engagement with cradle3080. The height of arms 3094 and 3096 relative to longitudinal edges3091 and 3092 may be based at least in part on the height or depth offirst enclosure 3022 and corresponding dimensions of driver 3200.Support surface 3098 may be disposed between arms 3094 and 3096 in anelevated position relative to longitudinal edges 3091 and 3092. Thelocation of support surface 3098 may be selected to accommodatecorresponding dimensions of driver 3200 and particularly handle 3206.

The spacing or gap formed between first arm 3094 and second arm 3096 maybe selected to accommodate the width of handle 3206 of driver 3200.Respective ribs 3100 may be formed approximate the end of each arm 3094and 3096 opposite from longitudinal edges 3091 and 3092. Ribs 3100preferably extend inwardly relative to associated arm 3094 and 3096. Thedimensions of arms 3094 and 3096, the gap formed therebetween, andassociated ribs 3100 may be selected to be compatible with forming asnug but releasable snap type fit with adjacent portions of handle 3206of driver 3200.

For some applications first wall 3104 and second wall 3106 may bedisposed between first end 3086 and supporting surface 3098 such asshown in FIG. 25. The spacing between first wall 3104 and second wall3106 may be selected to correspond with corresponding dimensions ofhandle 3206 of driver 3200 and particularly dimensions associated withtrigger assembly 3208. Walls 3104 and 3106 may cooperate with each otherto provide a “trigger guard” to prevent accidental activation of driver3200 when kit 3020 and/or 3020 a are in their first, closed position.

One or more holes 3108 may be formed in cradle 3080 approximate firstend 3086 and second end 3088. Holes 3108 may be sized to receive varioustypes of fasteners such as rivets and/or screws (not expressly shown).Such fasteners may be used to secure cradle 3080 at a desired locationwithin first enclosure 3022.

Materials used to form cradle 3080 may be relatively low cost but mustalso have sufficient durability for repeated insertion and removal of anassociated driver. For some applications arms 3094 and 3096 may bedesigned to allow insertion and removal of an associated driver at leastfive hundred times. Arms 3094 and 3096 may also have sufficientstiffness and strength to allow associated driver 3200 to snap intoplace. The stiffness of arms 3094 and 3096 may be selected such thatdriver 3200 will not be inadvertently released from cradle 3080 if kit3020 or 3020 a should be dropped or otherwise mishandled.

For embodiments such as shown in FIG. 28, second end 3088 (not expresslyshown) of cradle 3080 a may be modified to include electrical contactsused to charge a battery or other power source disposed in handle 3206of driver 3200. Electrical connector assembly 3070 may be disposed onexterior portions of wall 3034 a to accommodate inserting charging cable3072 extending from an appropriate charger (not expressly shown). Lights3074 and 3076 may be provided as part of electrical connector assembly3070 to indicate the status of a battery or other power source disposedin handle 3206 after each use of powered driver 3200 and to indicate thestatus of recharging powered driver 3200.

Various types of indicator lights may be used. For some applicationslight 3074 may be yellow to indicate that a battery (not expresslyshown) in power driver 3200 needs to be recharged. Light 3076 may begreen to indicate that the charging is not required or that charging ofassociated powered driver 3200 has been satisfactorily completed. Forsome applications, kit 3020 a will preferably be in its first, openposition during charging of powered driver 3200.

Prehospital and combat situations are often ideally suited to use “unitdose” containers of various types of medications. Emergency medicalpersonnel often need only a one-time dose of medication, such as anantidote for poison or epinephrine to stabilize the patient. Unit doseampules are widely used by paramedics to give a predetermined amount ofmedication for a particular indication. A limited number of drugs maysatisfactorily fill such needs.

Kit 3120 as shown in FIGS. 29A and 29B represents one example of a kitcontaining unit doses in accordance with teachings of the presentdisclosure. For some applications, kit 3120 may be carried separate frompreviously discussed kits 3020 and 3020 a. For other applications kit3120 may be disposed within kits 3020 and/or 3020 a. Kit 3120 is shownin FIG. 29B in its second, open position with cover 3140 removed toprovide access to ampules 3123-3127 containing respective unit doses ofmedication.

Kit 3120 may include base portion 3130 and cover 3140. Zipper 3122 orother types of closures may be satisfactorily used to releasably engagecover 3140 with base portion 3130. For some applications a pair ofzippers and a breakable seal such as shown in FIG. 23B may be used withkit 3120. Kit 3120 is shown in FIG. 29A in its first, closed positionwith cover 3140 releasably engaged with base portion 3130.

For embodiments such as shown in FIGS. 29A and 29B, kit 3120 may bedescribed as having a generally rectangular configuration with roundedcorners. Cover 3140 may be generally described as a hollow enclosuredefined in part by top layer 142 with four (4) walls extendingtherefrom. Walls 3143 and 3144 are shown in FIG. 29A. Interior portionsof cover 3140 are preferably open to accommodate storage of ampules3123-3127.

Base 3130 may be formed from a relatively thick layer of materialsatisfactory for use. A plurality of holes may be formed in interiorsurface 3032 of base 3130 satisfactory to accommodate releasably storingeach ampule 3123-3127 in a respective hole. The exterior configurationsof base 3130 may also be defined in part by walls and rounded cornerswhich are preferably compatible with the walls and rounded cornersassociated with cover 3140.

Base portion 3130 as shown in FIG. 29B may function as a rack releasablyholding a plurality of single use (unit dose) ampules which may meetmany (if not most) of an emergency medical service provider's immediateneeds. For example, ampule 3123 may contain epinephrine for cardiacarrest and life threatening allergies. Ampule 3124 may contain atropinefor cardiac arrest and chemical exposures. Ampule 3125 may containdiazepam for seizures and emergency sedation. Ampule 3126 may containamiodarone for cardiac arrhythmias. Ampule 3127 may contain narcan fordrug overdose. Each ampule 3123-3127 may be clearly labeled so that anappropriate drug may be quickly and accurately selected in an emergency.As shown in FIGS. 29A and 29B, kit 3120 may contain medications in aneasy to carry and maintain rack or stand such as base 3130. Kit 3120 mayinclude zip lock cover 3140 which is easy to remove in an emergency.

The ability to satisfactorily insert an IO device such as an IO needleat a desired insertion site may be problematic when a patient is movingor has the potential to move. Inserting an IO device in the wrong placemay expose a patient to potential harm. Patient movement may be ofspecial concern for patients suffering from status epilepticus orviolent patients (drug overdoses or mental status changes) that need tobe controlled for their safety and treatment. Epileptic patients mayshake violently for prolonged periods which makes starting aconventional IV nearly impossible. Likewise, it may be difficult toaccurately place an IO device at a desired insertion site in thesepatients. Although target areas for successful IO placement such as apatient's tibia and humerus are often larger than target areas forplacement of an IV device, problems with inserting an IO device at adesired insertion site may be minimized by using stabilization devicesand supporting structures incorporating teachings of the presentdisclosure. Such devices and supporting structures may be easy to apply,even in difficult field environments.

FIGS. 30, 33, 34, 35, 36 and 39 show various examples of an intraosseousdevice inserted into a patient's bone marrow to provide vascular accessin accordance with teachings of the present disclosure. Bone 3152 andassociated bone marrow 3154, shown in FIGS. 30, 33, 34, 35, 36 and 39,may be representative of the tibia in a patient's leg. The upper tibiaproximate a patient's knee may often be used as an insertion site for IOaccess to a patient's vascular system. A humerus may also be used as aninsertion site for IO access to a patient's vascular system.

FIG. 30 shows one example of an intraosseous device which may have beeninserted into a patient's bone marrow using a kit containing variousdevices and components in accordance with teachings of the presentdisclosure. For this example, intraosseous device 3160 may be generallydescribed as intraosseous (IO) needle 3160 having a hollow, longitudinalbore extending therethrough (not expressly shown). IO devices 3160 maybe releasably attached to page 2 of kits 3020 and/or 3020 a.

First end or tip 3161 of IO needle 3160 may be designed to drill or cutthrough bone 3152 and penetrate associated bone marrow 3154. Tip 3161may be open to allow communication of fluids with bone marrow 3154.Also, one or more side ports 3164 may be formed in IO needle 3160 toallow communication of fluids therethrough. Second end 3162 of IO needle3160 may have various types of connections including, but not limitedto, a conventional Luer lock connection (not expressly shown) associatedwith supplying IV fluids and medications to a patient.

Strap 3170 and supporting structure 3180 such as shown in FIGS. 30 and31 may be carried in a kit in accordance with teachings of the presentdisclosure. Strap 3170 may be formed from various types of elastomericand/or nonelastomeric materials compatible with contacting skin 3156 andother soft tissue covering a patient's bone at a selected insertionsight. The dimensions and configuration of strap 3170 may be selected toform satisfactory engagement with adjacent portions of leg 3150, an arm,or other desired sites for providing IO access to a patient's vascularsystem.

Strap 3170 may include first end 3171 and second end 3172 sized to beinserted through holes 3181 and 3182 of supporting structure 3180. Strap3170 and supporting structure 3180 cooperate with each other to preventaccidental removal or withdrawal of JO needle 3160 from an insertionsite. Strap 3170 and supporting structure 3180 also cooperate with eachother to prevent excessive movement or rocking of JO needle 3160relative to the insertion site.

Supporting structure 3180 may include relatively short, hollow cylinder3184 with a pair of flanges or wings 3186 extending therefrom. Holes3181 and 3182 may respectively be formed in each wing or flange 3186.Wings 3186 may be formed from relatively flexible material which willconform with adjacent portions of a patient's skin, soft tissue andbone. Hollow cylinder 3184 may be formed from relatively rigid materialto prevent undesired movement of associated 3010 needle 3160. Interiordimensions of hollow cylinder 3184 may correspond approximately with theexterior dimensions of IO needle 3160 to provide a relatively snug fittherebetween.

For embodiments such as shown in FIG. 32, supporting structure 3180 amay include wings or tabs 3186 a which have been modified to includerespective projections 3181 a and 3182 a extending there from. Strap3170 a may be modified as compared with strap 3170 by attachingrespective buckles 3174 with first end 3171 a and second end 3172 a.Each buckle 3174 may include respective hole 3176 sized to receiveassociated projection 3181 a and 3182 a formed on tabs 3186 a.

Supporting structure 3180 a may be placed at an JO insertion site.Buckle 3174 a at first end 3171 a of strap 3170 a may be releasablyengaged with corresponding projection 3181 a. Strap 3170 a may then beextended around patient's leg or other bone to allow engaging buckle3174 a at second end 3172 a with associated projection 3182 a. For suchapplications, strap 3170 a may be formed from elastomeric material.

For some applications supporting structure 3180 may be placed at aninsertion site prior to installing JO device 3160. JO device 3160 maythen be inserted through the longitudinal bore of supporting structure3180. For other applications an JO device with exterior dimensions andexterior configuration of the JO device may be compatible with interiordimensions 3188 of supporting structure 3180 may first be installed at adesired insertion site. Supporting structure 3180 may then be fittedover the installed JO device (not expressly shown) by placing the JOdevice through the longitudinal bore of supporting structure 3180. Strap3170 a may then be engaged with respective projections 3181 and 3182.

FIG. 33 shows IO needle 3160 inserted into bone marrow 3154. Supportingstructure 3180 b may be used to stabilize IO needle 3160 and limitexcessive movement relative to bone 3152. Supporting structure 3180 bmay be generally described as having a domed shape configuration. Thedimensions of supporting structure 3180 b may be selected to becompatible with a desired insertion site. A longitudinal bore or alongitudinal opening (not expressly shown) may extend through supportingstructure 3180 b. The longitudinal bore may have dimensions compatiblewith exterior dimensions of IO needle 3160. Supporting structure 3180 bmay be formed from various types of semi-rigid silicone based materialsand/or materials satisfactory for providing required support. A pair ofholes (not expressly shown) may be provided in supporting structure 3180b to accommodate the use of strap 3170. However, other straps such asshown in FIGS. 32, 36 and 37 and/or adhesive materials (not expresslyshown) may be satisfactory used to position supporting structure 3180 ata desired insertion site.

FIG. 34 shows IO 3160 inserted into bone 3152 and associated bone marrow3154. Strap 3170 may be placed around bone 3152 and attached tosupporting structure 3180 as previously described. Sensor 3178 may beattached to strap 3170 for use in measuring various parametersassociated with providing fluids and/or medications through IO device3160 to bone marrow 3154. Such parameters may include, but are notlimited to, pressure and/or changes in the size of a patient's leg,temperature and/or pulse rate. When sensor 3178 detects a preset valuefor one or more of these parameters, an alarm may be sounded. For someapplications sensor 3178 may be coupled with monitor 3190 and/or ageneral purpose computer (not expressly shown). The general purposecomputer may include one or more programs operable to stop infusion offluids and/or medication through associated IO device 3160 in the eventone or more parameters exceeds preset limits.

FIG. 35 shows IO device 3160 a inserted into bone 3152 and associatedbone marrow 3154. IO device 3160 a may be equipped with pressuretransducer 3192 proximate tip 3161 to measure intraosseous pressure. Forsome applications, a similar needle (not expressly shown) may be placedin a leg muscle to measure intra-compartment pressure.

Seal assembly 3195 may be used to isolate transducer wire 3196 so thatinfusions of fluids may proceed while, at the same time, measuringintravenous pressure at tip 3161. Measurements from sensor 3192 may beanalyzed by a computer (not expressly shown) to manage changes in apatient's condition by initiating pre-set increases in infusionpressure, controlling the rate of infusion or stopping infusion alltogether and alarming the patient and/or medical personnel if pressurelimits are exceeded.

FIGS. 36, 37 and 38 show one example of a supporting structure or guidewhich may be disposed at a desired insertion site such as the uppertibia proximate a patient's knee. Supporting structure or guide 3180 cmay be generally described as having a dome shaped configuration withcavity or recess 3194 formed therein and sized to receive anintraosseous device. For example, recess 3194 may be sized toaccommodate an intraosseous device such as penetrator assembly 3240. Seefor example FIG. 39.

Supporting structure or guide 3180 c may be formed from variouspolymeric and/or thermoplastic materials having desired rigidity andstrength to direct insertion of an intraosseous device at a de siredinsertion site. Supporting structure 3180 c may also be formed fromvarious types of elastomeric and/or nonelastomeric materialssatisfactory for use in forming a guide or supporting structure todirect insertion of an intraosseous device at a desired insertion site.

For some applications strap 3170 c may include one or more strips ofhook and loop type material 3198 (sometimes referred to as Velcro®strips) disposed proximate first end 3171 c and second end 3172 c ofstrap 3170 c. The configuration, size and dimensions of Velcro® strips3198 may be modified to allow strap 3170 c to releasably attachsupporting structure 3180 c with a leg or other portions of a patient'sbody having various dimensions. For some applications supportingstructure 3180 c may include target 3199 disposed within recess 3194 foruse by an operator to more precisely direct insertion of an associatedIO device at a desired insertion site.

FIG. 39 shows powered driver 3200 being used to insert penetratorassembly 3240 at an insertion site identified by guide or supportingstructure 3180 c. Powered driver 3200 may be further stabilized withvarious types of straps and/or medical grade tape (not expressly shown)prior to inserting penetrator assembly 3240.

FIGS. 40A and 41 show examples of manual drivers which may be carried ina kit in accordance with teachings of the present disclosure. For someapplications, a kit may contain only a powered driver or only a manualdriver. For other applications, a kit incorporating teachings of thepresent disclosure may include both a powered driver and a manualdriver. Examples of manual drivers are shown in U.S. patent applicationSer. No. 10/449,503, filed May 30, 2003, entitled “Apparatus and Methodto Provide Emergency Access To Bone Marrow,” now U.S. Pat. No.7,670,328; and U.S. patent application Ser. No. 11/042,912, filed Jan.25, 2005, entitled “Manual Intraosseous Device,” now U.S. Pat. No.8,641,715.

Manual driver 3200 a may include handle 3212 with drive shaft 216extending therefrom. Manual driver 3200 a may also include an optionalratchet mechanism (not expressly shown). Handle 3212 may be formed in avariety of shapes, such as with finger grips 3214. Handle 3212 may beformed from materials satisfactory for multiple uses or may be formedfrom materials satisfactory for one time or disposable use. Handle 3212may have an ergonomically designed shape suitable for grasping with ahand and/or fingers during manual insertion of an IO device into boneand associated bone marrow.

FIG. 40A shows an exploded view of manual driver 3200 a and penetratorassembly 3240. Penetrator assembly 3240 may include an outer penetratorsuch as a cannula, hollow tube or hollow drill bit and an innerpenetrator such as a stylet or trocar. Various types of outerpenetrators may be used to form a portion of penetrator assembly 3240.Various types of stylets and/or trocars may be disposed within an outerpenetrator.

For some applications penetrator assembly 3240 may include connector3250 with inner penetrator or trocar 3260 extending therefrom and hub3270 with outer penetrator or cannula 3280 extending therefrom.Connector 3250 and hub 3270 may be releasably engaged with each otherusing Luer type fittings, threaded connections or other suitablefittings formed on second end 3252 of connector 3250 and first end 3271of hub 3270. Outer penetrator 3280 may extend from second end 3272 ofhub 3270.

For some applications outer penetrator or cannula 3280 may be describedas a generally elongated tube sized to receive inner penetrator orstylet 3260 therein. Portions of inner penetrator 3260 may be disposedwithin a longitudinal passageway 3276 extending through outer penetrator3280. The outside diameter of inner penetrator 3260 and the insidediameter of longitudinal passageway 3276 may be selected so that innerpenetrator 3260 may be slidably disposed within outer penetrator 3280.Outer penetrator 3280 may be formed from stainless steel, titanium orother materials of suitable strength and durability to penetrate boneand magnetic characteristics to allow releasable engagement with disc3254.

Tip 3281 of outer penetrator 3280 and/or tip 3261 of inner penetrator3260 may be operable to penetrate bone and associated bone marrow. Theconfiguration of tips 3261 and/or 3281 may be selected to penetrate abone or other body cavities with minimal trauma. First end or tip 3261of inner penetrator 3260 may be trapezoid shaped and may include one ormore cutting surfaces. In one embodiment outer penetrator 3280 and innerpenetrator 3260 may be ground together as one unit during an associatedmanufacturing process. Inner penetrator 3260 may also include alongitudinal groove (not expressly shown) that runs along the side ofinner penetrator 3260 to allow bone chips and/or tissues to exit aninsertion site as penetrator assembly 3240 is drilled deeper into anassociated bone.

Hub 3270 may be used to stabilize penetrator assembly 3240 duringinsertion of outer penetrator 3280 into a patient's skin, soft tissueand adjacent bone at a selected insertion site. First end 3271 of hub3270 may be operable for releasable engagement or attachment withassociated connector 3250. Second end 3272 of hub 3270 may have a sizeand configuration compatible with an associated insertion site. Thecombination of hub 3270 with outer penetrator 3280 may sometimes bereferred to as a penetrator set or an intraosseous needle.

For some applications connector 3250 may be described as a generallycylindrical tube defined in part by first end 3251 and second end 3252.The exterior of connector 3250 may include an enlarged tapered portionadjacent to end 3251. A plurality of longitudinal ridges 3256 may beformed on the exterior of connector 3250 to allow an operator to graspassociated penetrator assembly 3240 during attachment with drive shaft3216. Longitudinal ridges 3256 also allow connector 3250 to be graspedfor disengagement from hub 3270 after outer penetrator 3280 has beeninserted into a bone and associated bone marrow. Disc 3254 may bedisposed within receptacle or opening 3256 for use in releasablyattaching connector 3250 with drive shaft 3216.

For some applications disc 3254 may be a magnet. For such applicationsdrive shaft 3216 may be formed from various types of metallic materialswith magnetic characteristics compatible with releasable engagement ofdrive shaft 3216 with the magnetic disc 3254 disposed in penetratorassembly 3240. For other applications a magnet (not expressly shown) maybe formed on the end of drive shaft 3216. For such applications disc3254 may be formed from various types of metallic material withcharacteristics compatible with releasably engaging penetrator assembly3240 with the magnet formed on the end of drive shaft 3216.

First end 3271 may have a generally cylindrical pin type configurationcompatible with releasably engaging hub 3270 with second end or box end3252 of connector 3250. Second end 3252 of connector 3250 may includeopening 3258 sized to receive first end 3271 of hub 3270 therein.Threads 3259 may be formed in opening 3258 adjacent to second end 3252of connector 3250. Threads 3273 may be formed proximate end 3271 of hub3270. Threads 3259 and 3273 may be used to releasably attach connector3250 with first end 3271 of hub 3270.

For some applications end 3272 of hub 3270 may have the generalconfiguration of flange. Angular slot or groove 3274 sized to receiveone end of protective cover or needle cap 3290 may be formed in end3272. Slot or groove 3274 may be used to releasable engage cover 3290with penetrator assembly 3240. For some applications cover 3290 may bedescribed as a generally hollow tube having rounded end 3292. Cover 3290may be disposed within associated slot 3274 to protect portions of outerpenetrator 3280 and inner penetrator 3260 prior to attachment with adriver. Cover 3290 may include a plurality of longitudinal ridges 3294formed on the exterior thereof. Longitudinal ridges 3294 cooperate witheach other to allow installing and removing cover or needle cap 3290without contaminating portions of an associated penetrator. Cover 3290may be formed from various plastics and/or metals.

FIG. 40B shows container 3230 with penetrator assembly 3240 disposedtherein. One of the benefits of the present disclosure includesproviding a kit which allows an operator to remove a driver from aholder contained within the kit using one hand. The other hand of theoperator may remove container 3230 from page two of divider 3050 andopen lid 3232 of container 3230 using one hand. Drive shaft 3216 may bereleasably engaged with receptacle 3258 in end 3251 of connector 3250.

FIG. 41 shows another example of a manual driver which may be used toinsert an IO device into bone marrow in accordance with teachings of thepresent disclosure. Manual driver 3200 b may include pistol grip typehandle 3212 b with drive shaft 3216 extending therefrom. Manual driver3200 b may also include an optional ratchet mechanism (not expresslyshown). Manual driver 3200 b may be releasably engaged with penetratorassembly 3240 or any other IO device incorporating teachings of thepresent disclosure.

Examples of acute and chronic conditions which may be treated usingpowered drivers, intraosseous devices, kits, and proceduresincorporating teachings of the present disclosure include, but are notlimited to, the following:

-   -   Anaphylaxis (epinephrine, steroids, antihistamines, fluids, and        life support)    -   Arrhythmia (anti-arrhythmics, electrolyte balance, life        support);    -   Burns (fluid replacement, antibiotics, morphine for pain        control);    -   Cardiac arrest (epinephrine, atropine, amiodarone, calcium,        xylocaine, magnesium);    -   Congestive heart failure (life support, diuretics, morphine,        nitroglycerin);    -   Dehydration (emergency port for life support, antibiotics,        blood, electrolytes);    -   Diabetic Ketoacidosis (life support, electrolyte control, fluid        replacement);    -   Dialysis (emergency port for life support, antibiotics, blood,        electrolytes);    -   Drug overdose (naloxone, life support, electrolyte correction);    -   Emphysema (life support, beta adrenergics, steroids);    -   Hemophiliacs (life support, blood, fibrin products, analgesics);    -   Osteomyelitis (antibiotics directly into the site of infection,        analgesics);    -   Pediatric applications (shock, dehydration, nutrition,        electrolyte correction);    -   Renal Failure (both acute and chronic kidney failure, inability        to purify blood);    -   Seizures (anti-seizure medications, life support, fluid        balance);    -   Shock (life support fluids, pressor agents, antibiotics,        steroids);    -   Sickle cell crisis (fluid, morphine for pain, blood,        antibiotics); and    -   Trauma (emergency port for life support fluids, antibiotics,        blood, electrolytes).

More than 35,000 Advanced Cardiac Life Support (ACLS) ambulances are inservice in the U.S. Each is equipped with emergency drugs and devices.Most are required to carry intraosseous needles and paramedics aretrained in their use for pediatric emergencies. Kits incorporatingteachings of the present disclosure may be used to administermedications and treats before permanent damage to a patient occurs.

More than 4,000 emergency rooms in the U.S. are required to treatlife-threatening emergencies like shock trauma and cardiac arrest. ERsare stocked with the latest devices and equipment to help patientsreceive state-of-the-art treatment. However, there is no moreexasperating situation for the physician or potentially catastrophiccondition for the critical patient, than the inability to establishintravenous access. Kits with IO devices incorporating teachings of thepresent disclosure may provide a simple and straightforward solution forextremely difficult clinical problems.

Hospitals are required to provide crash carts on every patient ward. Itis estimated that 6,000 U.S. hospitals stock more than 60,000 crashcarts. These crash carts are stocked with defibrillators, IV accessdevices, including central venous catheters, IV fluids and drugs forcommon emergencies. Nurses and other healthcare workers using thesecrash carts are often inexperienced in such emergencies and havedifficulty establishing IV access. A kit with IO devices incorporatingteachings of the present disclosure may provide the long sought IValternative for difficult patients.

Automatic injectors are widely used in the military. During DesertStorm, combat soldiers carried an atropine auto-injector for nerve gaspoisoning. Current auto-injectors are limited to intramuscularinjections. The Kits with IO devices may vastly expand the scope oftreatment to include intravenous drugs, without having to be skilled inthe technique of intravenous insertion.

Most acute care hospitals in the U.S. operate Intensive Care Units(ICUs) for seriously ill patients. Establishing and maintaining venousaccess in these patients is often a challenge. IO access may be awelcome procedure for administration of drugs and fluids to thesecritical patients.

Ten percent of the population experience a major seizure in theirlifetime and more than 2,500,000 people in the United States haveepilepsy. Grand mal seizures represent one of the most dramatic eventsin medicine. During the seizure, which usually lasts 60 to 90 seconds,patients typically fall to the ground, become rigid with trunk andextremities extended, and shake violently. The most dreaded progressionof seizures is status epilepticus, a condition defined as a continuousseizure lasting more than 30 minutes or two or more seizures that occurwithout full conscious recovery between attacks. Convulsive statusepilepticus requires urgent, immediate treatment. Patients are at riskfor serious injury, hypoxemia, circulatory collapse, permanent braindamage and death. The overall mortality of convulsive status epilepticusis up to 35 percent.

Intravenous access with a large bore needle/catheter must be establishedto administer anticonvulsant medications. These include a benzodiazepinefollowed by phenytoin and/or phenobarbitol for immediate seizure controland prevention of further seizures. There are no satisfactory oral,rectal, or intramuscular medications that will control statusepilepticus.

The problem facing clinicians and paramedics treating patients withstatus epilepticus is the difficulty establishing venous access. Withoutadequate venous lines none of the effective anticonvulsants can begiven. During seizures the violent shaking makes accessing asatisfactory vein difficult. Often after the line is established,further shaking dislodges the IV or causes it to infiltrate.

Further, caregivers are at great risk of puncturing themselves with aneedle when attempting to establish venous access in a patient during aseizure. Through no fault of their own, seizing patients, by jerking andthrashing around, turn the safest procedure into a terrifying venture.Doctors, nurses, and paramedics work in mortal fear of contracting AIDSand hepatitis through an inadvertent puncture with a contaminatedneedle.

In an attempt to solve the venous access problem, emergency physiciansand intensivists have turned to establishing a central line (intravenouscatheter placed in a large central vein such as the subclavian orfemoral vein). However, with this method, even under ideal conditions,there is an increased incidence of serious side effects such aspneumothorax, hemothorax, inadvertent puncture of a major artery,infection, venous thrombosis, and embolus. In the case of a patient withstatus epilepticus, this method becomes increasingly difficult anddangerous for all of the above-mentioned reasons. Therefore, mostdoctors are reluctant to even attempt a central line until seizures haveceased.

Dialysis patients who often come to the emergency room in lifethreatening situations such as pulmonary edema (water on the lungs) orhigh potassium leading to cardiac arrest. These patients typically havetroublesome or non-existent veins. The IO access may give these patientshope for a better quality of live and decrease their mortality.

Drug overdose victims, often comatose, generally require immediate IVaccess to give antidotes and life saving medications such as Narcan.These patients usually have difficult venous access due to long termabuse of their veins. IO access may give these patients an alternateroute for delivery of medications and fluids while improving the safetyof the healthcare workers.

Trauma victims and attempted suicide patients, often in shock due toblood loss, may also require swift replacement of fluids to save vitalorgans. Because of the shock condition (decreased blood pressure), veinscollapse and are often impossible to find. IO access may save preciousminutes for paramedics and trauma surgeons responsible for their care.

Although the present invention and its advantages have been described indetail, it should be understood that various changes, substitutions andalternations can be made herein without departing from the spirit andscope of the invention as defined by the following claims.

What is claimed is:
 1. An apparatus for penetrating bone and accessingbone marrow, the apparatus comprising: a penetrator assembly operable topenetrate bone and bone marrow, the penetrator assembly comprising: atrocar including a stylet and a first connector, the first connectorforming a first connecting piece at a first end of the first connector,and a penetrator assembly connector at a second end of the firstconnector opposite to the first end of the first connector; and an outerpenetrator including a hollow cannula and a second connector, the secondconnector forming a second connecting piece complementary to the firstconnecting piece on the first connector of the trocar, the hollowcannula configured to receive the stylet of the trocar, and the firstconnecting piece of the trocar configured to engage the secondconnecting piece of the outer penetrator; and a powered drill having ahousing defining a handle, the housing enclosing a motor and a powersupply and associated circuitry to power the motor, the powered drillfurther including a switch connected to the power supply and operable toactivate the motor to rotate the penetrator assembly when saidpenetrator assembly is releasably attached to the powered drill; thepowered drill further comprising a third connector, the third connectorconfigured to connect to the penetrator assembly connector of thepenetrator assembly, and the third connector further configured toreleasably lock the penetrator assembly connector into place with thepowered drill; wherein the second connector of the outer penetrator isconfigured to connect to an intravenous tubing; wherein the power supplycomprises a battery disposed within the housing and configured to supplypower to the motor; and the powered drill further including a batteryindicator operable to indicate a level of the battery.
 2. The apparatusaccording to claim 1, wherein the battery is a rechargeable battery, andwherein the handle further comprises a charging contact and associatedcharging circuitry operable to charge the rechargeable battery.
 3. Theapparatus according to claim 2, wherein the battery indicator furthercomprises a plurality of lights operable to indicate a status of therechargeable battery.
 4. The apparatus according to claim 1, wherein thebattery indicator further comprises a plurality of lights operable toindicate a status of the battery.
 5. The apparatus according to claim 1,wherein the hollow cannula comprises a cutting tip, and the cutting tipof the hollow cannula and a tip of the stylet are operable to penetratebone marrow as a single drilling unit.
 6. The apparatus according toclaim 5, further comprising a magnetic connection to releasably lock thepenetrator assembly connector into place with the powered drill.
 7. Theapparatus according to claim 5, wherein the outer penetrator and thestylet are ground together as one unit during a manufacturing process.8. The apparatus according to claim 5, wherein the battery is arechargeable battery, and the handle further comprises a chargingcontact and associated charging circuitry operable to charge therechargeable battery.
 9. The apparatus according to claim 8, wherein thebattery indicator further comprises a plurality of lights operable toindicate a status of the rechargeable battery.
 10. The apparatusaccording to claim 5, wherein the battery indicator further comprises aplurality of lights operable to indicate a status of the battery. 11.The apparatus according to claim 1, further comprising a magneticconnection to releasably lock the penetrator assembly connector intoplace with the powered drill.
 12. The apparatus according to claim 11,wherein the outer penetrator further comprises a flange operable to abutskin of a patient during an insertion procedure for stabilizing thepenetrator assembly.
 13. The apparatus according to claim 11, whereintrocar includes a magnetic disc operable to allow the magneticconnection between the penetrator assembly connector and the powereddrill.
 14. The apparatus according to claim 11, wherein trocar includesa metal disc operable to allow the magnetic connection between thepenetrator assembly connector and the powered drill.
 15. The apparatusaccording to claim 1, wherein the outer penetrator further comprises aflange operable to abut skin of a patient during an insertion procedurefor stabilizing the penetrator assembly.
 16. The apparatus according toclaim 1, wherein the battery is a rechargeable battery, and the handlefurther comprises a charging contact and associated charging circuitryoperable to charge the rechargeable battery, wherein the batteryindicator further comprises a plurality of lights operable to indicate astatus of the rechargeable battery, wherein the hollow cannula comprisesa cutting tip, and the cutting tip of the hollow cannula and a tip ofthe stylet are operable to penetrate bone marrow as a single drillingunit, and wherein the outer penetrator further comprises a flangeoperable to abut skin of a patient during an insertion procedure forstabilizing the penetrator assembly.
 17. The apparatus according toclaim 1, wherein the battery is a rechargeable battery, and the handlefurther comprises a charging contact and associated charging circuitryoperable to charge the rechargeable battery, wherein the batteryindicator further comprises a plurality of lights operable to indicate astatus of the rechargeable battery, wherein the hollow cannula comprisesa cutting tip, and the cutting tip of the hollow cannula and a tip ofthe stylet are operable to penetrate bone marrow as a single drillingunit, and further comprising a magnetic connection to releasably lockthe penetrator assembly connector into place with the powered drill. 18.The apparatus according to claim 1, wherein the second connecting piececomprises a connecting piece locking mechanism configured to lock intoposition on the first connecting piece.
 19. The apparatus according toclaim 1, wherein the switch is disposed on an outer surface of thehousing and proximate to a first end of the housing on which the thirdconnector is provided.
 20. The apparatus according to claim 1, whereinthe penetrator assembly further includes a penetrator shield configuredto shield a tip of the stylet of the trocar.